Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial 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: NCT01422785
Recruitment Status : Unknown
Verified August 2011 by Joshua Zeichner, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : August 24, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Joshua Zeichner, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE August 12, 2011
First Posted Date  ICMJE August 24, 2011
Last Update Posted Date August 24, 2011
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne [ Time Frame: Weeks 2, 4, 8, 12 ]
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
  • Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit. [ Time Frame: Weeks 2, 4, 8, 12 ]
    Change in PIH score from baseline will be assessed. (based on a 6 point scale)
  • Total number of adverse events. [ Time Frame: Weeks 2, 4, 8, 12 ]
    Safety/drug-tolerance evaluated at each visit (total number of adverse events)
  • Change in Subject Self Assessment Scoring Scale [ Time Frame: Weeks 2, 4, 8, 12 ]
    Patient rates current severity of their acne.
  • Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL) [ Time Frame: Weeks 2, 4, 8, 12 ]
    Acne-QoL as completed by patient.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Official Title  ICMJE A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
Brief Summary There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
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%/tretinoin 0.025% gel alone
    Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
  • Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
    wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.
Study Arms  ICMJE
  • Active Comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
    Intervention: Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
  • Active Comparator: clindamycin / tretinoin gel plus benzoyl peroxide
    Intervention: Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 22, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females ≥ 12 years old.
  • Subjects must be in good general health as confirmed by medical history and physical examination.
  • Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
  • Clear diagnosis of facial acne vulgaris for at least 3 months.
  • Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
  • Disease must be stable or slowly worsening for more than one week prior to entering the study.
  • Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.

Exclusion Criteria:

  • Females who are pregnant, attempting to conceive, or breastfeeding.
  • Subjects with known hypersensitivity to study drug.
  • Subjects with very severe acne (PGA score of 5)
  • Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
  • Subjects with a current active skin malignancy or infection.
  • Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
  • Subjects who have received systemic antibiotics within 2 weeks.
  • Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
  • Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
  • Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
  • Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
  • Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
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 NCT01422785
Other Study ID Numbers  ICMJE GCO 10-1602
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua Zeichner, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Zeichner, Joshua, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zeichner, Joshua, M.D.
Verification Date August 2011

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