Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects
Brief Summary: This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Participants with each half-face randomized to one of the two following treatments:

* Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
* Vehicle gel

The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.


Options:
A: Inclusion Criteria:

* Documented diagnosis of acne vulgaris.
* Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline.
* Investigator Static Global Assessment of 3 or 4 at Baseline.

Exclusion Criteria:

* Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
* Subjects with cystic acne lesions.
* Facial hair that may obscure the accurate assessment of acne grade.
* History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms.
* Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity.
* Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
* Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid) within the past 2 weeks.
* Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics within the past 4 weeks.
* Use of topical corticosteroids on the face or systemic corticosteroids within the past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other than for facial acne lesions) steroids is acceptable.
* Use of systemic retinoids, such as Isotretinoin, within the past 6 months.
* Concomitant use of the following types of facial products: astringents, toners, abradants, hair removal wax, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β hydroxy acids.
* Concomitant use of medications that are reported to exacerbate acne, (eg, vitamins such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib, aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) as these may impact efficacy assessments. Iron supplements and folate are acceptable.
* Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
* Known hypersensitivity or previous allergic reaction to any component(s) or excipient(s) of the study products.
* Use of any investigational medications or treatments within the past 4 weeks.
* Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product and have not been prescribed for the treatment of Acne Vulgaris. Subjects that have been treated with estrogens, as described above, androgens, or anti androgenic agents for more than 12 consecutive weeks prior to start of study treatment are allowed to enroll as long as they do not expect to change dose, medication, or discontinue use during the study.
* Evidence of recent alcohol or drug abuse (in the opinion of the investigator).
* Live in the same household as currently enrolled subjects.
* Employee of the investigator, a clinical research organization, or Stiefel Laboratories who is involved in the study or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
B: Inclusion Criteria:

1. Male and female subjects between 12 and 45 years of age, inclusive age will be calculated by date of birth, from 0 at birth.
2. Subjects who have:

   i. A minimum of 17 but not more than 60 facial inflammatory lesions (papules plus pustules), and no more than 1 facial nodular lesion, with NO cystic lesions.

   and ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
3. Subjects who have an ISGA score of 2 or 3 at Baseline.
4. Subjects 18 years of age or older must provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent must provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
5. Subjects who are willing and able to complete the study, to understand and comply with the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
6. Subjects who are in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
7. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active females of childbearing potential participating in the study must use a medically acceptable method of contraception for at least 6 consecutive months prior to start of study treatment, and must use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Medically acceptable contraceptive methods include the following:

   * Hormonal contraception, including oral, injectable, or implantable methods started at least 6 months prior to screening.
   * Reliable barrier methods include condoms and diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable.

Females who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.

Subjects who have been treated with estrogens, androgens, or anti-androgenic agents used for prevention of pregnancy (and not for control of acne) for at least 6 consecutive months prior to the first dose of investigational product may enrol as long as they do not expect to change dose, drug, or discontinue use during the study.

Exclusion Criteria:

1. Female subjects who are pregnant, trying to become pregnant, or who are lactating.
2. Subjects who have cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
3. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
4. Subjects who have facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
5. Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
6. Subjects who have used a prohibited medication, or undergone a prohibited procedure or treatment within the required washout period.
7. Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, or excipients of the investigational product.
8. Subjects who are employees of a clinical research organization involved in the study, Stiefel, or GSK or who are an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee, the investigator, or his/her study staff.
9. Subjects who have a member of the same household in this study at the same time.
10. Subjects who have used traditional remedies known to affect acne vulgaris within the last 4 weeks.
11. Subjects who have had any major illness within 30 days before study enrolment.
12. Subjects who have any other condition that in the judgement of the investigator would put the subject at unacceptable risk for participation in the study.
13. Subjects who have participated in any clinical trials or taken any investigate drugs within 4 weeks before study enrolment.
C: Inclusion Criteria:

1. Male or female, who is 12 years of age or older at Screening visit.
2. Clinical diagnosis of acne vulgaris with facial involvement.
3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

1. More than 2 acne nodules on the face at Baseline visit.
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
6. Use of hormonal contraceptives solely for control of acne.
D: Main Inclusion Criteria:

* Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:

  1. Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
  2. A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
  3. No more than two acne nodules (less than or equal to \[\>=\] 1 centimeter \[cm\]); and
  4. A minimum of 10 atrophic acne scars in total (upper than 2 millimeters \[mm\]) (excluding the nose)
* Participants with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face.
* Participants with skin phototype of I to IV on Fitzpatrick's scale.

Main Exclusion Criteria:

* Participants with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment.
* Prior failure to treatment with TactuPump® Forte (Adapalene 0.3% - BPO 2.5%).
* Participants with more than 3 excoriated acne lesions.
* Participants with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn.
* Female participant who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application.
* Male participant with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures.
* Participants having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, antibacterials, antiseptics, other anti-inflammatory drugs or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Photodynamic therapy, laser therapy, microdermabrasion for acne (3 months).
* Participants having received at least one of the following systemic treatments: Corticosteroids (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), antibiotics (except penicillin) (1 month); Spironolactone (3 months) / Drospirenone (3 months, unless dose is stable since at least 3 months); Oral retinoids (6 months); Cyproterone acetate / Chlormadinone acetate (6 months); Immunomodulators (3 months).

Answer: D