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## Complete Summary

#### GUIDELINE TITLE

Acne management.

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Acne management.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2006 May. 33 p. \[53 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Acne management. Bloomington
(MN): Institute for Clinical Systems Improvement (ICSI); 2003 Sep. 32 p.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [October 6, 2006,
    iPLEDGE](http://www.fda.gov/medwatch/safety/2006/safety06.htm#Isotretinoin):
    An update to iPLEDGE that will eliminate one element of the program.

-   [August 12, 2005,
    iPLEDGE](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Accutane):
    Approval of a strengthened risk management program, called iPLEDGE,
    for Accutane and generic isotretinoin.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Acne

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Internal Medicine\
Pediatrics

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Health Plans\
Hospitals\
Managed Care Organizations\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To improve the selection of appropriate treatment for patients with
    acne based on severity

-   To increase the number of patients who report satisfaction with the
    treatment of their acne

-   To increase the number of patients with appropriate follow up for
    acne treatment

#### TARGET POPULATION

All patients with acne vulgaris

**Note**: This guideline excludes rosacea and folliculitis.

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Review of possible contributing factors including hormonal,
    mechanical, and medications

2.  Assess objective severity of acne (e.g., mild, moderate, or severe)

3.  Assess psychosocial impact of acne

**Treatment/Management**

1.  Development of treatment plan based on factors such as goals of
    treatment, skin type, patient adherence, and relative cost of
    treatment

2.  Topical treatments

    -   Over-the-counter products that may contain benzoyl peroxide,
        salicylic acid, glycolic acid, sulfur, or resorcinol

    -   Prescriptions products, including benzoyl peroxide, retinoids,
        azelaic acid, and single- and combination-drug antibiotics

3.  Oral antibiotics in combination with topical treatment

4.  Patient education, follow-up, and encouragement

5.  Adjunctive therapy such as oral contraceptives, spironolactone, oral
    retinoids (isotretinoin), intra-lesional injections with
    corticosteroids

6.  Referral to dermatologist

**Note**: Light therapy was considered but not recommended due to
inadequate evidence.

#### MAJOR OUTCOMES CONSIDERED

-   Patient factors such as contributing medical conditions and
    medications

-   Severity of acne (presence and quantity of papules, pustules,
    nodules, cysts, and total lesions)

-   Quality of life and other psychosocial factors

-   Results/outcome of treatments

-   Side effects of treatment

-   Patient compliance and adherence

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Key conclusions (as determined by the work group) are supported by a
conclusion grading worksheet that summarizes the important studies
pertaining to the conclusion. Individual studies are classed according
to the system presented below, and are designated as positive, negative,
or neutral to reflect the study quality.

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results of different studies or because of serious doubts about
generalizability, bias, design flaws, or adequacy of sample size.
Alternatively, the evidence consists solely of results from a limited
number of studies of weak design for answering the question addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Study Quality Designations**:

The quality of the primary research reports and systematic reviews are
designated in the following ways on the conclusion grading worksheets:

**Positive**: indicates that the report or review has clearly addressed
issues of inclusion/exclusion, bias, generalizability, and data
collection and analysis.

**Negative**: indicates that these issues (inclusion/exclusion, bias,
generalizability, and data collection and analysis) have not been
adequately addressed.

**Neutral**: indicates that the report or review is neither
exceptionally strong nor exceptionally weak.

**Not Applicable**: indicates that the report is not a primary reference
or a systematic review and therefore the quality has not been assessed.

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Non-randomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

The guideline developers reviewed published cost analyses.

#### METHOD OF GUIDELINE VALIDATION

Clinical Validation-Pilot Testing\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**Institute Partners: System-Wide Review**

The guideline draft, discussion, and measurement specification documents
undergo thorough review. Written comments are solicited from clinical,
measurement, and management experts from within the member medical
groups during an eight-week period of \"Critical Review.\"

Each of the Institute\'s participating medical groups determines its own
process for distributing the guideline and obtaining feedback.
Clinicians are asked to suggest modifications based on their
understanding of the clinical literature coupled with their clinical
expertise. Representatives from all departments involved in
implementation and measurement review the guideline to determine its
operational impact. Measurement specifications for selected measures are
developed by the Institute for Clinical Systems Improvement (ICSI) in
collaboration with participating medical groups following general
implementation of the guideline. The specifications suggest approaches
to operationalizing the measure.

**Guideline Work Group: Second Draft**

Following the completion of the \"Critical Review\" period, the
guideline work group meets 1 to 2 times to review the input received.
The original guideline is revised as necessary, and a written response
is prepared to address each of the suggestions received from medical
groups. Two members of the Committee on Evidence-Based Practice
carefully review the Critical Review input, the work group responses,
and the revised draft of the guideline. They report to the entire
committee their assessment of two questions: (1) Have the concerns of
the medical groups been adequately addressed? (2) Are the medical groups
willing and able to implement the guideline? The committee then either
approves the guideline for pilot testing as submitted or negotiates
changes with the work group representative present at the meeting.

**Pilot Test**

Medical groups introduce the guideline at pilot sites, providing
training to the clinical staff and incorporating it into the
organization\'s scheduling, computer, and other practice systems.
Evaluation and assessment occur throughout the pilot test phase, which
usually lasts for three months. Comments and suggestions are solicited
in the same manner as used during the \"Critical Review\" phase.

The guideline work group meets to review the pilot sites\' experiences
and makes the necessary revisions to the guideline, and the Committee on
Evidence-Based Practice reviews the revised guideline and approves it
for implementation.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Note from the National Guideline Clearinghouse (NGC) and the Institute
for Clinical Systems Improvement (ICSI)**: In addition to updating their
clinical guidance, ICSI has developed a new format for all guidelines.
Key additions and changes include: combination of the annotation and
discussion section; the addition of \"Key Points\" at the beginning of
most annotations; the inclusion of references supporting the
recommendations; and a complete list of references in the Supporting
Evidence section of the guideline. For a description of what has changed
since the previous version of this guidance, refer to [Summary of
Changes \-- May -
2006](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/other_health_care_conditions/acne/acne__management_of_2.html).

The recommendations for acne management are presented in the form of an
algorithm with 10 components, accompanied by detailed annotations. An
algorithm is provided for [Acne
Management](http://www.guideline.gov/algorithm/5014/NGC-5014.html);
clinical highlights and selected annotations (numbered to correspond
with the algorithm) follow.

Class of evidence (A-D, M, R, X) and conclusion grade (I-III, Not
Assignable) definitions are repeated at the end of the \"Major
Recommendations\" field.

**Clinical Highlights**

-   Patient perception of improvement is the best measure of successful
    treatment. (*Annotation #4*)

-   Although acne is not a life threatening disease, the clinician must
    be aware of potentially debilitating psychosocial effects.
    (*Annotation #4*)

-   Treatment with both a topical retinoid and a topical antibiotic has
    been found to be an effective course of treatment. (*Annotation #5*)

-   Customize a treatment plan that the patient will be able to follow
    according to his/her needs. (*Annotations #6, 8*)

-   The patient needs to understand that acne may get worse before it
    gets better. It typically takes eight weeks of treatment before a
    response is noted. (*Annotation #7*)

-   Isotretinoin therapy is highly regulated. (*Annotation #9*)

[**Algorithm
Annotations**](http://www.guideline.gov/algorithm/5014/NGC-5014.html)

1.  **Patient Presents for Treatment of Acne/Provider Observes Acne**

> When presented with acne in office visit scheduled for other reason,
> identify comfort with condition and desire for treatment.

2.  **Review Possible Contributing Factors**

> **Hormonal**
>
> Signs of androgen excess would include:

-   Precocious puberty

-   Hirsutism

> Possible causes of androgen excess would include:

-   Polycystic ovary disease

-   Adrenal tumor

-   Ovarian tumor

-   Pituitary tumor

> **Mechanical**
>
> On occasions physical occlusion may contribute to acne. For example:
> hockey masks; oil-based cosmetics (although most cosmetics today are
> water based).
>
> ***Evidence supporting this recommendation is of classes: D, R***
>
> **Medications**
>
> There are many medications that may contribute to the development of
> acne. In addition to treating the acne, consideration may be given to
> discontinuing these medications. Refer to the original guideline
> document for a list of medications that may contribute to the
> development of acne.
>
> ***Evidence supporting this recommendation is of classes: D, R***

3.  **Assess Objective Severity of Acne**

> Acne severity is the most important clinical diagnostic tool in
> studies reviewed. For simplification, the guideline developer is
> following the Agency for Healthcare Research and Quality\'s (AHRQ)
> recommendation to divide acne into three severity grades: mild,
> moderate, and severe. There are a number of other ways of grading acne
> that are used clinically and in research. None, however, is
> universally accepted. Additionally, psychological impact or the
> presence of scarring may play a role in assigning a severity grade to
> the patient.
>
> The following diagnostic tool was designed as a guideline for three
> lesion counts on the face but may be applicable to grading the
> severity of acne on the trunk as well.

a.  **Mild Acne**:

> Mild acne is characterized by predominance of comedones (fewer than
> 20), or fewer than 15 inflammatory papules, or a comedone/papule count
> of fewer than 30 on the face.

b.  **Moderate Acne**:

> Moderate acne predominantly exhibits papules and pustules (about 15-50
> lesions) with comedones and rare cysts. Total lesion (comedone,
> papule, pustule) count may range from 30 to 125 on the face.

c.  **Severe Acne**:

> Severe acne is characterized primarily with the presence of
> inflammatory nodules and cysts. Also present are comedones, papules,
> and pustules or total lesion count of greater than 125 on the face.
>
> **Definitions**:

-   **Closed Comedone (whitehead)**: non-inflamed (non-red) follicular
    opening containing a keratotic plug with a thin overlying epidermal
    membrane

-   **Open Comedone (blackhead)**: non-inflamed (non-red) follicular
    opening containing a keratotic plug that appears black

-   **Papule**: small round to oval red elevation of the skin (1-4 mm)

-   **Pustule**: resembles a papule with a central pocket of pus

-   **Nodule/Cyst**: poorly marginated red tender, sometimes draining
    0.2- to 3.0-cm indurated mass in the skin

> ***Evidence supporting this recommendation is of classes: M, R***

4.  **Assess Psychosocial Impact of Acne**

> It is important to assess the psychosocial effect of acne. Studies
> using \"quality of life\" surveys show a variety of significant
> impacts, most frequently, anxiety and depression. Decreased
> self-esteem, social withdrawal, anger, conduct disorders, and
> decreased employability have been reported in other studies. The
> clinical severity of the acne does not always predict the severity of
> the psychosocial impacts. Effective treatment of acne can decrease
> these negative effects.
>
> If significant psychosocial effects are present, consider a more
> aggressive initial treatment (such as combination therapy and closer
> follow-up) than might be indicated by the objectively observed
> severity alone. Patient perception of improvement is the best measure
> of successful treatment.
>
> ***Evidence supporting this recommendation is of classes: C, D, R***

5.  **Choose Treatment Plan**

> There are multiple treatment modalities that have been demonstrated
> effective in the treatment of acne. \[*Conclusion Grade I: See
> Conclusion Grading Worksheet A- Annotation #5 (Choose Treatment Plan)
> in the original guideline document.*\]
>
> Resistance to antibiotics is rising but does not appear to decrease
> effectiveness of treatment. \[*Conclusion Grade II: See Conclusion
> Grading Worksheet B \-- Annotation #5 (Resistance to Antibiotics) in
> the original guideline document*.\]
>
> When initiating treatment it is important to consider the goals of
> therapy. Treatment goals should include:

-   Achieving clearance of acne

-   Prevention of scarring

-   Learning to cope with psychological stress resulting from the acne

> **Considerations**:

-   Patient skin type (oily to dry)

    -   for very oily skin consider a gel or solution

    -   for very dry skin choose creams or lotions

-   If more than one topical is being used (for example a retinoid and a
    topical antibiotic), have patient apply one in the morning and the
    other at night.

-   If multiple agents are used, they should be from different classes.
    For example, a benzoyl peroxide and a topical antibiotic.

-   Customize treatment to enhance adherence. For example, can the
    patient reach their back to apply the product? Importance of
    avoiding food, especially dairy products, one hour before or two
    hours after taking tetracycline.

> **Relative Cost Value**
>
> Costs for treatment modalities may vary significantly and should be
> considered in treatment selection. Refer to the original guideline
> document for cost ranges and key for a 30-day supply.

a.  **Topical Treatment of Acne**

> An example of treatment for mild acne may include benzoyl peroxide, a
> topical antibiotic, or a combination product one to two times daily;
> or a topical retinoid once daily in addition to the above. See tables
> in this annotation in the original guideline document for description
> of medications.
>
> *Over-the-counter Topical Products*
>
> A wide variety of over-the-counter (OTC) topical products are
> available to the patient for self-treatment of acne. A complete
> listing is beyond the scope of this publication. The most common
> ingredient in OTC products is benzoyl peroxide in concentrations up to
> 10%. (Many of the expensive acne systems advertised contain benzoyl
> peroxide and offer no advantages over commercial products.) Salicylic
> acid in concentrations of 0.5% to 2% is a keratolytic found in many
> OTC acne products. Products may also contain glycolic acid (an
> alpha-hydroxy acid), sulfur, or resorcinol. **When evaluating a new
> patient it is helpful to know which products they may have tried**.
>
> *Benzoyl Peroxide*
>
> Benzoyl peroxide is available without a prescription in products such
> as Clearasil® and by prescription in the products listed in the
> original guideline document. It is also available in combination with
> antibiotics (see \"Topical Antibiotics\" table in the original
> guideline document).
>
> *Topical Retinoids for Acne*
>
> Topical retinoids (see \"Topical Retinoids\" table in the original
> guideline document) increase the turnover of follicular epithelial
> cells, promote drainage of comedones, and inhibit new comedone
> (blackhead, whitehead) formation. Topical retinoids are generally
> applied in the evening.
>
> *Azelaic Acid*
>
> Azelaic acid is a naturally occurring dicarboxylic acid which has been
> shown to be effective in reducing both inflammatory and
> non-inflammatory acne lesions (see \"Azelaic Acid\" table in the
> original guideline document.)
>
> *Topical Antibiotics for Acne*
>
> Propionibacterium acnes (P. acnes) is an anaerobic bacterium present
> within the pilosebaceous follicles. It is thought that this
> microorganism plays a role in acne-associated inflammation. The
> antibiotics used to treat acne have been shown to reduce colonization
> of P. acnes and may also possess direct anti-inflammatory effects.
> In-vitro resistance of P. acnes to commonly used antibiotics has been
> increasing but the clinical significance of this is uncertain.
> However, it has been recommended that antibiotics be used with either
> topical retinoids or benzoyl peroxide. (See \"Single Drug Products\"
> and \"Combination Products\" tables in the original guideline
> document.)

b.  **Topical Treatment and Oral Antibiotics for Acne**

> An example for moderate/severe acne may include examples listed in
> section 5a of the original guideline document with the addition of an
> oral antibiotic while continuing with the topical treatment. (See
> \"First Line Antibiotics\" and \"Second Line Antibiotics\" tables in
> the original guideline document for descriptions of products.)
>
> Antibiotics such as azithromycin and others are being used in acne but
> studies are preliminary and concrete recommendations regarding their
> use cannot be made at this time.
>
> ***Evidence supporting this recommendation is of classes: A, C, D,
> R***

6.  **Patient Education**

> Successful management of acne is dependent on a successful partnership
> between the health care team and the patient. Non-adherence is one of
> the biggest causes of treatment failure. Clear guidelines regarding
> treatment, possible adverse effects, and realistic expectations of
> treatment outcomes should be given to the patient to achieve the best
> possible outcome. Ongoing patient education, follow-up, encouragement,
> and maintaining a positive approach are vital. Because acne can be so
> devastating for many, early intervention with a proactive treatment
> plan may well prevent some of the long-term physical and psychosocial
> consequences.
>
> **Myths and Facts**
>
> An integral component of the prevention and treatment of acne is
> discussion of the facts and expulsion of the myths.
>
> **MYTH**: Any acne medication works immediately.
>
> ***FACT***: It can take at least eight weeks of a prescribed treatment
> regimen for the patient to see any improvement. **Acne may even get
> worse before it gets better**.
>
> **MYTH**: Acne is a result of poor hygiene.
>
> ***FACT***: As a result of this myth, people tend to overwash their
> skin, often scrubbing hard with abrasive cleansers. Cleaning the skin
> too often may aggravate acne and cause flare-ups. Wash face twice per
> day with a mild soap; pat dry, and use appropriate acne treatment.
> Acne is not caused by dirt or surface oil.
>
> **MYTH**: Washing many times a day will diminish acne.
>
> ***FACT***: Under normal circumstances, wash no more than two times a
> day with mild soap and lukewarm, not very hot or very cold, water.
>
> **MYTH**: Washing with abrasive soaps, cleansing granules,
> astringents, vigorous scrubbing, or a buff puff will clear up acne on
> the face.
>
> ***FACT***: Using your fingertips or a soft wash cloth is best.
>
> **MYTH**: Picking your acne will make it go away.
>
> ***FACT***: This may cause scarring. Do not pick at acne lesions.
>
> **MYTH**: Once acne has cleared up, it will be gone forever.
>
> ***FACT***: There is no cure for acne. If acne medication is
> discontinued, acne will probably flare.
>
> **MYTH**: Stress causes acne.
>
> ***FACT***: Stress alone does not cause acne but may exacerbate
> psychological reaction to the acne. Acne is caused by overactive oil
> glands stimulated by androgens mixing with dead skin cells. This is
> particularly true during the teenage years when androgen production is
> at its highest.
>
> **MYTH**: Eating chocolate and sugar will cause acne.
>
> ***FACT***: There is no evidence to support this. Certain foods may
> make some patients\' acne worse and obviously should be avoided. No
> specific food has been proven to worsen acne. No diet has been shown
> to be beneficial.
>
> **MYTH**: Teenagers are the only ones affected by acne.
>
> ***FACT***: Acne affects adults as well as children. The body produces
> androgens throughout life. The circumstances around adult acne may be
> a little different than in teens, particularly in women. Women between
> 18 and 40 years may have breakouts that occur most frequently when
> they are premenstrual.
>
> ***Evidence supporting this recommendation is of class: R***
>
> **Home Care Recommendations**

-   Topical medications should be applied to dry skin.

-   Try to avoid abrasive soaps, cleansing granules, astringents, and
    vigorous scrubbing.

-   Under normal circumstances, wash no more than two times a day with
    your fingertips or a soft wash cloth.

-   Patients who are treated with acne medications often develop dry
    skin. Use fragrance-free, non-comedogenic, oil-free moisturizers.
    These moisturizers will not clog pores and therefore should not
    cause black- or whiteheads.

-   For patients who choose to use makeup to cover their acne lesions, a
    water-based, non-comedogenic makeup should be used. Avoid oil-based
    cosmetics. Use makeup sparingly.

-   Do not cover acne with bandages or tight fitting clothing.

-   If a topical retinoid or photosensitizing antibiotics are
    prescribed, recommend staying out of the sun as much as possible and
    stress the use of sunscreens.

> ***Evidence supporting this recommendation is of class: R***

7.  **Follow-Up 6-12 Weeks/Satisfactory Response?**

> There is no clear evidence to support a specific duration of any
> treatment for acne. However, clinical experience and clinical trials
> suggest that a minimum treatment period of 6 to 12 weeks is needed
> before an improvement will be noted in most patients.

8.  **Assess Outcome and Adherence**

> Asking non-threatening, open-ended questions during patient interviews
> can be a useful method of assessing medication adherence. The
> interview should include probes for factors that contribute to
> non-adherence including adverse reactions, misunderstandings of
> asymptomatic or chronic disease treatment, depression, cognitive
> impairment, complex dosing regimens, and financial constraints.

A.  Assess the patient\'s knowledge of his/her medication and medical
    condition.

B.  Assess the patient\'s medication administration process.

C.  Assess the patient\'s barriers to adherence.

> To view sample assessment questions, refer to the original guideline
> document.
>
> ***Evidence supporting this recommendation is of class: R***

9.  **Modify Treatment Plan**

> **Consider Different/Additional Medications**
>
> It may be necessary to switch to a different class of topical acne
> medication. For example: if the patient is on a benzoyl peroxide
> product or a combination product and is not responding, consider
> switching to a once daily topical retinoid and a once daily topical
> anti-infective. For moderate to severe acne, consider adding an oral
> antibiotic or switching the current oral antibiotic. Selection is
> based on patient specific factors.
>
> **Consider Adjunctive Therapy**

-   **Oral contraceptives**

> The addition of combination oral contraceptives has been shown to be
> effective in the treatment of acne. \[*Conclusion Grade I: See
> Conclusion Grading Worksheet C - Annotation #9 (Oral Contraceptives)
> in the original guideline document*.\]
>
> Treatment with a combined oral contraceptive (estrogen and progestin)
> is an alternative for women who fail conventional acne therapies. Oral
> contraceptives are effective for the treatment of acne due to their
> androgen modulating properties. It is the estrogen component of
> combined oral contraceptives that reduces androgen production and
> decreases the amount of free and active testosterone by increasing the
> production of sex hormone binding globulin. Progestin-only oral
> contraceptives are not effective and may worsen acne. Responses may
> not be seen for 3 to 6 months, with some patients showing a flare of
> symptoms during early cycles. Although some progestins have exhibited
> androgenic properties during in vitro and animal studies, all
> combination oral contraceptives have antiandrogenic properties due to
> the estrogen component. To ensure adherence with therapy, the ideal
> product is one that has the lowest incidence of adverse effects for a
> particular patient. Products with Food and Drug Administration (FDA)
> indications for acne include Estrostep® and Ortho Tri-cyclen®.

-   **Spironolactone**

> Spironolactone is a medication primarily used in the treatment of
> hypertension. Due to its antiandrogenic effect, it has occasionally
> been used to treat adult-onset acne in women when other treatments
> have been ineffective. It is the effects of testosterone that are felt
> to be a contributing factor to the development of acne in adult
> females. The drug acts by blocking the effects of testosterone on the
> oil glands and hair follicles of the female patient. The result is a
> reduction in oil production that may lead to improvement of their
> acne. The optimal dosage varies, but ranges from 50 to 200 mg daily.
> Response may take two to three months\*. The drug should not be used
> in pregnancy. Women of child-bearing age should use birth control
> methods while taking the medication. Side effects are rare, usually
> related to menstrual irregularity, mild gastrointestinal (GI) upset,
> or headache. The medication may be taken for one to two years with
> periodic rest periods.
>
> \*Spironolactone can cause decreased sodium and increased potassium.
> Levels should be initially measured and carefully monitored at
> appropriate intervals.

-   **Oral Retinoids**

> Isotretinoin is the only oral retinoid approved for use in acne and is
> a well established teratogen. Although causality has not been
> determined for depression and suicide, this is an ongoing concern. In
> view of these factors its use is highly regulated by the FDA.
>
> Only providers registered with the iPLEDGE program may prescribe
> Isotretinoin. For information about this program conduct an internet
> search using: iPLEDGE program. This program is scheduled to start
> March 1, 2006 and replaces the existing System to Manage Accutane
> Related Teratogenicity (S.M.A.R.T.) program.

-   **Intra-lesional injections**

> There are rare circumstances in which you may consider injecting large
> acne cysts with a corticosteroid for short term cosmetic improvement.
> Each injection carries a risk of causing skin atrophy. Repeated
> injections are not recommended. The concentration of Triamcinolone
> varies from 2 to 10 mg/cc. The stock 10-, 25- or 40- mg/mL steroid
> suspension should be diluted with lidocaine and only enough injected
> through a 1-mL syringe with a 27- or 30- gauge needle to distend the
> cyst slightly (usually 0.025 mL to 0.1 mL).

-   **Light Therapy**

> There continue to be numerous studies about light treatment for acne,
> including blue light and photodynamic therapy with and without
> pretreatment with topical medications. At this time, the evidence is
> inadequate to make a recommendation about the efficacy and safety of
> these treatments.
>
> **Consider Dermatology Referral**
>
> Dermatologists treat all forms of acne, particularly severe cases. For
> those patients with severe inflammatory acne that has not improved
> with previously described medications, a retinoid, isotretinoin
> (Accutane), may be considered. Dermatologists may be helpful to guide
> you in any point of the algorithm.
>
> ***Evidence supporting this recommendation is of class: A, R***
>
> For most current information regarding Isotretinoin:
>
> <http://www.fda.gov/cder/drug/infopage/accutane/default.htm>

10. **Maintenance**

> If stable on current topicals, continue treatment indefinitely.
>
> If stable on topical and systemic antibiotics, after clearance is
> achieved for 1 to 3 months consider tapering oral antibiotics and
> continue topicals indefinitely.

**Definitions**:

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusions because of inconsistencies among
the results from different studies or because of serious doubts about
generalizability, bias, research design flaws, or inadequacy of sample
sizes. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence that directly supports or
refutes the conclusion.

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Non-randomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

#### CLINICAL ALGORITHM(S)

A detailed and annotated clinical algorithm is provided for [Acne
Management](http://www.guideline.gov/algorithm/5014/NGC-5014.html).

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is classified for selected
recommendations (see \"Major Recommendations\").

In addition, key conclusions contained in the Work Group\'s algorithm
are supported by a grading worksheet that summarizes the important
studies pertaining to the conclusion. The type and quality of the
evidence supporting these key recommendations (i.e., choice among
alternative therapeutic approaches) is graded for each study.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Effective treatment of acne can decrease such negative effects of acne
as decreased self-esteem, social withdrawal, anger, conduct disorders,
and decreased employability. Patient perception of improvement is the
best measure of successful treatment.

#### POTENTIAL HARMS

See the appropriate tables in the original guideline document for
information on adverse effects of benzoyl peroxide, topical retinoids,
azelaic acid, topical antibiotics, combination products, and first- and
second-line oral antibiotics.

**Spironolactone**

-   Side effects are rare, usually related to menstrual irregularity,
    mild gastrointestinal upset, or headache. Women of childbearing age
    should use birth control methods while taking the medication.

-   Spironolactone can cause decreased sodium and increased potassium.
    Levels should be initially measured and carefully monitored at
    appropriate intervals.

**Oral Retinoids**

-   Isotretinoin is a well established teratogen.

-   Although causality has not been determined for depression and
    suicide this is an ongoing concern.

-   In view of these factors its use is highly regulated by the U.S.
    Food and Drug Administration (FDA).

**Intra-lesional Injections**

-   Injections carry the risk of causing skin atrophy.

-   Repeated injections are not recommended.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

*Topical Retinoids, Oral Retinoids, Spironolactone*. Contraindications
include pregnancy.

*Sulfacetamide, Sulfamethoxazole/Trimethoprim*. Contraindications
include allergy to sulfonamides.

*Doxycycline, Minocycline, and Tetracycline*. Contraindications include
children \<8 years old, pregnant or nursing women.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These clinical guidelines are designed to assist clinicians by
    providing an analytical framework for the evaluation and treatment
    of patients, and are not intended either to replace a clinician\'s
    judgment or to establish a protocol for all patients with a
    particular condition. A guideline will rarely establish the only
    approach to a problem.

-   This medical guideline should not be construed as medical advice or
    medical opinion related to any specific facts or circumstances.
    Patients are urged to consult a health care professional regarding
    their own situation and any specific medical questions they may
    have.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Once a guideline is approved for general implementation, a medical group
can choose to concentrate on the implementation of that guideline. When
four or more groups choose the same guideline to implement and they wish
to collaborate with others, they form a guideline action group.

In the action groups, each medical group sets specific goals they plan
to achieve in improving patient care based on the particular
guideline(s). Each medical group shares its experiences and supporting
measurement results within the action group. This sharing facilitates a
collaborative learning environment. Action group learnings are also
documented and shared with interested medical groups within the
collaborative.

Currently action groups may focus on one guideline or a set of
guidelines such as hypertension, lipid treatment, and tobacco cessation.

The following detailed measurement strategies are presented to help
close the gap between clinical practice and the guideline
recommendations.

*Priority Aims and Suggested Measures*

1.  Improve the selection of appropriate treatment for patients with
    acne based on severity.

> Possible measures for accomplishing this aim:

a.  Percentage of patients with mild acne treated with appropriate
    topical medications at first visit.

b.  Percentage of patients with severe acne treated with appropriate
    topical and systemic medications at first visit.

```{=html}
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```
2.  Increase the number of patients who report satisfaction with the
    treatment of their acne.

> Possible measure for accomplishing this aim:

a.  Percentage of patients who report satisfaction with treatment one
    year after initiation of treatment

```{=html}
<!-- -->
```
3.  Increase the number of patients with appropriate follow up for acne
    treatment.

> Possible measure for accomplishing this aim:

a.  Percentage of patients who have documentation of follow-up in 6 to
    12 weeks after initiation of treatment (excludes isotretinoin).

At this point in the development for this guideline, there are no
specifications written for possible measures listed above. The Institute
for Clinical Systems Improvement (ICSI) will seek input from the medical
groups on what measures are of most use as they implement the guideline.
In a future revision of the guideline, measurement specifications may be
included.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Patient Resources\
Pocket Guide/Reference Cards

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Acne management.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2006 May. 33 p. \[53 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2002 Nov (revised 2006 May)

#### GUIDELINE DEVELOPER(S)

Institute for Clinical Systems Improvement - Private Nonprofit
Organization

#### GUIDELINE DEVELOPER COMMENT

Organizations participating in the Institute for Clinical Systems
Improvement (ICSI): Affiliated Community Medical Centers, Allina Medical
Clinic, Altru Health System, Aspen Medical Group, Avera Health,
CentraCare, Columbia Park Medical Group, Community-University Health
Care Center, Dakota Clinic, ENT Specialty Care, Fairview Health
Services, Family HealthServices Minnesota, Family Practice Medical
Center, Gateway Family Health Clinic, Gillette Children\'s Specialty
Healthcare, Grand Itasca Clinic and Hospital, HealthEast Care System,
HealthPartners Central Minnesota Clinics, HealthPartners Medical Group
and Clinics, Hutchinson Area Health Care, Hutchinson Medical Center,
Lakeview Clinic, Mayo Clinic, Mercy Hospital and Health Care Center,
MeritCare, Mille Lacs Health System, Minnesota Gastroenterology,
Montevideo Clinic, North Clinic, North Memorial Care System, North
Suburban Family Physicians, Northwest Family Physicians, Olmsted Medical
Center, Park Nicollet Health Services, Pilot City Health Center, Quello
Clinic, Ridgeview Medical Center, River Falls Medical Clinic, Saint
Mary\'s/Duluth Clinic Health System, St. Paul Heart Clinic, Sioux Valley
Hospitals and Health System, Southside Community Health Services,
Stillwater Medical Group, SuperiorHealth Medical Group, University of
Minnesota Physicians, Winona Clinic, Ltd., Winona Health

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425;
telephone, (952) 814-7060; fax, (952) 858-9675; e-mail:
<icsi.info@icsi.org>; Web site: [www.icsi.org](http://www.icsi.org/).

#### SOURCE(S) OF FUNDING

The following Minnesota health plans provide direct financial support:
Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica,
Metropolitan Health Plan, PreferredOne and UCare Minnesota. In-kind
support is provided by the Institute for Clinical Systems Improvement\'s
(ICSI) members.

#### GUIDELINE COMMITTEE

Committee on Evidence-Based Practice

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group Members*: Claire Neely, MD (Work Group Leader)
(HealthPartners Medical Group) (Pediatrics); Mark Davis, MD (Mayo
Clinic) (Dermatology); Jennifer Lee, MD (North Clinic) (Dermatology);
Chester Dejon, MD (Sioux Valley Hospitals and Health System) (Family
Medicine); Stacie Lenssen, MD (Avera Health) (Family Medicine); Paul
Spinner, MD (CentraCare) (Family Medicine); Jennifer Bailey, RN
(HealthPartners Medical Group) (Health Education); Maureen Guay, RPh
(HealthPartners Medical Group) (Pharmacy); Amy Murphy, MHHA (Institute
for Clinical Systems Improvement) (Measurement and Implementation
Advisor); Brent Metfessel, MD, MPH (Institute for Clinical Systems
Improvement) (Evidence Analyst); Heidi Groven, RN, MS (Institute for
Clinical Systems Improvement) (Facilitator)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

In the interest of full disclosure, Institute for Clinical Systems
Improvement (ICSI) has adopted the policy of revealing relationships
work group members have with companies that sell products or services
that are relevant to this guideline topic. The reader should not assume
that these financial interests will have an adverse impact on the
content of the guideline, but they are noted here to fully inform
readers. Readers of the guideline may assume that only work group
members listed below have potential conflict of interest to disclose.

No work group members have potential conflicts of interest to disclose.

ICSI\'s conflict of interest policy and procedures are available for
review on ICSI\'s website at [www.icsi.org](http://www.icsi.org/).

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Acne management. Bloomington
(MN): Institute for Clinical Systems Improvement (ICSI); 2003 Sep. 32 p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Institute for Clinical Systems
Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/).

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Acne management. Executive summary. Bloomington (MN): Institute for
    Clinical Systems Improvement, 2006 May. 1 p. Electronic copies:
    Available from the [Institute for Clinical Systems Improvement
    (ICSI) Web
    site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/other_health_care_conditions/acne/acne__management_of_2.html).

-   ICSI pocket guidelines. April 2006 edition. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2006. 298 p.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### PATIENT RESOURCES

The following is available:

-   Acne management. Bloomington (MN): Institute for Clinical Systems
    Improvement, 2006 May. 21 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[Institute for Clinical Systems Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/for_patients_families/acne_management__for_patients___families_.html).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This summary was completed by ECRI on April 21, 2004. This NGC summary
was updated by ECRI on June 15, 2006. This summary was updated by ECRI
on November 14, 2006 following the updated FDA advisory on iPLEDGE.

#### COPYRIGHT STATEMENT

This NGC summary (abstracted Institute for Clinical Systems Improvement
\[ICSI\] Guideline) is based on the original guideline, which is subject
to the guideline developer\'s copyright restrictions.

The abstracted ICSI Guidelines contained in this Web site may be
downloaded by any individual or organization. If the abstracted ICSI
Guidelines are downloaded by an individual, the individual may not
distribute copies to third parties.

If the abstracted ICSI Guidelines are downloaded by an organization,
copies may be distributed to the organization\'s employees but may not
be distributed outside of the organization without the prior written
consent of the Institute for Clinical Systems Improvement, Inc.

All other copyright rights in the abstracted ICSI Guidelines are
reserved by the Institute for Clinical Systems Improvement, Inc. The
Institute for Clinical Systems Improvement, Inc. assumes no liability
for any adaptations or revisions or modifications made to the abstracts
of the ICSI Guidelines.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
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All guidelines summarized by NGC and hosted on our site are produced
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Guidelines represented on the NGC Web site are submitted by guideline
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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008