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Phase 4 Completed N=26 Randomized Single-blind Treatment

Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

Source: ClinicalTrials.gov NCT01047189 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne — 88; 61 Percent of doses

Summary

The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.

Outcome Measures

OutcomeResultp-value
PRIMARY
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
88; 61
SECONDARY
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
-51; -32 0.05

Eligibility Criteria

Inclusion Criteria

  • Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
  • Subjects must sign written informed consent and agree to come for all study visits.

Exclusion Criteria

  • Use of experimental drugs within 1 month prior to initiation of study therapy.
  • Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
  • Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
  • Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
  • Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
  • History of hypersensitivity to any of the formulation components;
  • Facial skin cancer or facial actinic keratosis;
  • Use of any photosensitizing agents.
  • Use of isotretinoin within the last 6 months.
  • Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
  • Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01047189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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