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Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00713609
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE July 7, 2008
First Posted Date  ICMJE July 11, 2008
Results First Submitted Date  ICMJE November 12, 2016
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and up to Week 12 ]
    The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
  • Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [ Time Frame: Baseline and up to Week 12 ]
    An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
The absolute change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have a minimum 2-grade improvement in ISGA score from baseline to week 12. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) [ Time Frame: Baseline and up to Week 12 ]
    The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
  • Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
    An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
The percent (%) change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have an ISGA score of 0 or 1 at week 12. [ 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 Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Official Title  ICMJE A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris
Brief Summary

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed Description

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Benzoyl peroxide gel
    5% benzoyl peroxide in a gel applied topically once a day
  • Drug: Clindamycin gel
    1% clindamycin phosphate applied topically once a day
  • Drug: Tazarotene cream
    0.1 % tazarotene in a cream applied topically once a day
  • Drug: Vehicle gel
    Vehicle gel is an identical gel without the active ingredients
  • Drug: Vehicle cream
    Vehicle cream is an identical cream without the active ingredients
Study Arms  ICMJE
  • Experimental: 1
    Benzoyl peroxide/clindamycin gel + tazarotene cream
    Interventions:
    • Drug: Benzoyl peroxide gel
    • Drug: Clindamycin gel
    • Drug: Tazarotene cream
  • Active Comparator: 2
    Benzoyl peroxide/clindamycin gel + vehicle cream
    Interventions:
    • Drug: Benzoyl peroxide gel
    • Drug: Clindamycin gel
    • Drug: Vehicle cream
  • Active Comparator: 3
    Benzoyl peroxide gel + tazarotene cream
    Interventions:
    • Drug: Benzoyl peroxide gel
    • Drug: Tazarotene cream
  • Active Comparator: 4
    Clindamycin gel + tazarotene cream
    Interventions:
    • Drug: Clindamycin gel
    • Drug: Tazarotene cream
  • Active Comparator: 5
    Vehicle gel+ tazarotene cream
    Interventions:
    • Drug: Tazarotene cream
    • Drug: Vehicle gel
  • Placebo Comparator: 6
    Vehicle gel + vehicle cream
    Interventions:
    • Drug: Vehicle gel
    • Drug: Vehicle 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: August 6, 2010)
591
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2008)
600
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
  • Subjects must have acne on their face.
  • Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
  • Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
  • Subjects must be able to complete the study and to comply with study instructions.

Exclusion Criteria:

  • Subjects who are pregnant, trying to become pregnant, or breast-feeding.
  • Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
  • History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
  • Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
  • Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
  • Other exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, 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 NCT00713609
Other Study ID Numbers  ICMJE 114570
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2017

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