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

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01047189
First received: January 11, 2010
Last updated: January 24, 2017
Last verified: November 2011
January 11, 2010
January 24, 2017
March 2009
October 2009   (Final data collection date for primary outcome measure)
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 [ Time Frame: 12 weeks ]
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
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 via a MEMS cap. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01047189 on ClinicalTrials.gov Archive Site
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ]
The change (dynamic assessment) from Baseline to Week 12 (or end of treatment) in the Investigator Global Assessment of acne. [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
    applied once daily for 12 weeks
    Other Name: Ziana
  • Drug: clindamycin 1% gel
    Topical clindamycin applied each morning for 12 weeks
  • Drug: tretinoin 0.025% cream
    Tretinoin 0.025% cream each evening for 12 weeks
  • Experimental: 1
    Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
    Intervention: Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
  • Active Comparator: 2
    Generic clindamycin 1% gel plus tretinoin 0.025% cream
    Interventions:
    • Drug: clindamycin 1% gel
    • Drug: tretinoin 0.025% cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01047189
00007137
No
Not Provided
Not Provided
Steven R. Feldman, Wake Forest University Health Sciences
Wake Forest University
Medicis Pharmaceutical Corporation
Principal Investigator: Steven R Feldman, MD, Ph.D Wake Forest University Health Sciences
Wake Forest University Health Sciences
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP