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Completed

NCT Number: NCT01047189

Adherence to Study Medication 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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clindamycin phosphate 1.2% and tretinoin 0.025%

Drug

applied once daily for 12 weeks

Other names: Ziana

Clindamycin 1% Gel

Drug

Topical clindamycin applied each morning for 12 weeks

tretinoin 0.025% cream

Drug

Tretinoin 0.025% cream each evening for 12 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Collaborators

  • Medicis Pharmaceutical Corporation

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2010
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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