Clinical trial NCT01422785: A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Official title: A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: Zeichner, Joshua, M.D.
Sponsor class: INDIV
First posted: 2011-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.


Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 12 years old.
* Subjects must be in good general health as confirmed by medical history and physical examination.
* Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
* Clear diagnosis of facial acne vulgaris for at least 3 months.
* Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
* Disease must be stable or slowly worsening for more than one week prior to entering the study.
* Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.

Exclusion Criteria:

* Females who are pregnant, attempting to conceive, or breastfeeding.
* Subjects with known hypersensitivity to study drug.
* Subjects with very severe acne (PGA score of 5)
* Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
* Subjects with a current active skin malignancy or infection.
* Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
* Subjects who have received systemic antibiotics within 2 weeks.
* Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
* Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
* Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
* Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
* Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Primary outcomes:
measure: Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
timeFrame: Weeks 2, 4, 8, 12
Secondary outcomes:
measure: Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
timeFrame: Weeks 2, 4, 8, 12
measure: Total number of adverse events.
timeFrame: Weeks 2, 4, 8, 12
measure: Change in Subject Self Assessment Scoring Scale
timeFrame: Weeks 2, 4, 8, 12
measure: Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
timeFrame: Weeks 2, 4, 8, 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt Sinai Hospital - Dept of Dermatology
state: New York
Study officials:
References: