Recruiting

Clindamycin & Tretinoin

Sponsor:

Zeichner, Joshua, M.D.

Code:

NCT01422785

Conditions

Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

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

Study Details

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 ID

NCT01422785

Start date

Jul, 2011

Status verified date

Aug, 2011

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

active comparator: clindamycin / tretinoin gel plus benzoyl peroxide

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

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.

Primary outcome 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 [ Time Frame: Weeks 2, 4, 8, 12 ]

Central Contacts and Locations

Central contacts

Vicky Wong

212-241-3288

Locations

Mt Sinai Hospital - Dept of Dermatology

Recruiting

New York, New York, United States, 10029

Contacts

Vicky Wong

212-241-3288

Principal Investigator:

Joshua Zeichner, MD

More Information

Sponsor

Zeichner, Joshua, M.D.

Last update posted

Aug 24, 2011

Last verified

Aug, 2011

Keywords

  • Acne Vulgaris

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zeichner, Joshua, M.D. on 2011-08-24.