A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
| Status: | Recruiting |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| Contact: | Vicky Wong |
| Phone: | 212-241-3288 |
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
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.
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.
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.
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