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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

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ClinicalTrials.gov Identifier: NCT01047189
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : October 17, 2011
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE January 11, 2010
First Posted Date  ICMJE January 12, 2010
Results First Submitted Date  ICMJE July 1, 2011
Results First Posted Date  ICMJE October 17, 2011
Last Update Posted Date September 10, 2018
Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
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 ]
Change History Complete list of historical versions of study NCT01047189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
The change (dynamic assessment) from Baseline to Week 12 (or end of treatment) in the Investigator Global Assessment of acne. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2010)
40
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047189
Other Study ID Numbers  ICMJE IRB00007137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE Medicis Pharmaceutical Corporation
Investigators  ICMJE
Principal Investigator: Steven R Feldman, MD, Ph.D Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

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