A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

Sponsor

Zeichner, Joshua, M.D. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01422785

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone	Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
Active Comparator: clindamycin / tretinoin gel plus benzoyl peroxide	Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.

Arm

Intervention/Treatment

Active Comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening

Active Comparator: clindamycin / tretinoin gel plus benzoyl peroxide

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths

wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.

Outcome Measures

Primary Outcome Measures

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 [Weeks 2, 4, 8, 12]
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.

Secondary Outcome Measures

Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit. [Weeks 2, 4, 8, 12]
Change in PIH score from baseline will be assessed. (based on a 6 point scale)
Total number of adverse events. [Weeks 2, 4, 8, 12]
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
Change in Subject Self Assessment Scoring Scale [Weeks 2, 4, 8, 12]
Patient rates current severity of their acne.
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL) [Weeks 2, 4, 8, 12]
Acne-QoL as completed by patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.