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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
ClinicalTrials.gov Identifier:
NCT01047189
First received: January 11, 2010
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
Drug: clindamycin 1% gel
Drug: tretinoin 0.025% cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap


Secondary Outcome Measures:
  • The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
applied once daily for 12 weeks
Other Name: Ziana
Active Comparator: 2
Generic clindamycin 1% gel plus tretinoin 0.025% cream
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047189

Locations
United States, North Carolina
Wake Forest University Health Sciences, Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Medicis Pharmaceutical Corporation
Investigators
Principal Investigator: Steven R Feldman, MD, Ph.D Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier: NCT01047189     History of Changes
Other Study ID Numbers: 00007137
Study First Received: January 11, 2010
Results First Received: July 1, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
Mild to moderate acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Tretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014