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

NCT ID: NCT01422785

Last Updated: 2011-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

Group Type: ACTIVE_COMPARATOR

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

Intervention Type: DRUG

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

clindamycin / tretinoin gel plus benzoyl peroxide

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeichner, Joshua, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Joshua Zeichner

Zeichner, Joshua, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mt Sinai Hospital - Dept of Dermatology

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vicky Wong

Role: CONTACT

212-241-3288

Facility Contacts

Vicky Wong

Role: primary

212-241-3288

Other Identifiers

GCO 10-1602

Identifier Type: -

Identifier Source: org_study_id