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Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers

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: NCT01254162
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mimetica Pty Limited

Tracking Information
First Submitted Date  ICMJE December 2, 2010
First Posted Date  ICMJE December 6, 2010
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
A 20% reduction in sebum production as measured by the Sebumeter [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
Assess the safety and tolerability of the product when applied daily to the forehead for 28 days [ Time Frame: 28 days ]
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 Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
Official Title  ICMJE A 4-Week, Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate the Potential of Topically Applied 0.75% (w/w) MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
Brief Summary To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.
Detailed Description This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control. Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo. Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group. One group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the forehead for 28 consecutive days, and the other will receive placebo under the identical regimen. Enrollment will be staggered to allow monitoring of safety and tolerability. A lead cohort will include approximately 20 subjects (10 in the MTC896 Group and 10 in the Placebo Group). Application on additional subjects will not be initiated until the lead cohort has completed the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Oily Skin
  • Seborrhea
Intervention  ICMJE Drug: MTC896 Gel
0.75% w/w gel applied daily for 28 days to the forehead
Study Arms  ICMJE Experimental: Placebo Gel
Intervention: Drug: MTC896 Gel
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: December 2, 2010)
135
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Are healthy males;
  • 2. Are between 18 and 65 years of age;
  • 3. Have self-perceived oily skin confirmed by a clinical assessment;
  • 4. Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
  • 5. Have a negative urine drug screening test result;
  • 6. Have a negative HIV and hepatitis screening test result;
  • 7. Agree to use adequate contraceptive precautions (ie, use of condoms) during the conduct of the study;
  • 8. Have a body mass index (BMI) of 19 to 34 kg/m2;
  • 9. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
  • 10. Are willing to abstain from using any facial treatment products or personal care products (moisturizer, sunscreen, hair spray, etc) on the forehead during the study;
  • 11. Are willing to avoid sun exposure and to protect the forehead with a hat/visor;
  • 12. Are fluent in the English language;
  • 13. Complete a standard Medical Screening form as well as a Medical Personal History form; and
  • 14. Read, understand, and provide a signed informed consent.

Exclusion Criteria:

  • 1. Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
  • 2. Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
  • 3. Are not willing to refrain from using systemic/topical analgesics such as aspirin (81 mg daily aspirin will be allowed at the discretion of the PI), Aleve, Motrin, Advil, or Nuprin for 24 hours prior to and during the study (use of acetaminophen will be permitted);
  • 4. Are using systemic/topical corticosteroids in the test area for 3 weeks prior to and during the study, or systemic/ antihistamines for 24 hours prior to and during the study;
  • 5. Are using topical retinoids, products containing benzoyl peroxide, salicylic acid, or alpha-hydroxy acids for 2 weeks prior to and during the study; or systemic retinoids within 3 months prior;
  • 6. Are using any medication which, in the opinion of the investigator, will interfere with the study evaluations;
  • 7. Have seborrheic dermatitis and/or active atopic dermatitis/eczema in or around the test sites;
  • 8. Have a known allergy and/or hypersensitivity to constituents present in the study products;
  • 9. Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
  • 10. Have received treatment for any type of internal cancer within 5 years prior to study enrollment;
  • 11. Have a history of, or are currently being treated for skin cancer;
  • 12. Are currently participating in any clinical testing; and/or
  • 13. Have received any investigational treatment(s) within 4 weeks prior to study enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01254162
Other Study ID Numbers  ICMJE MCL10001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mimetica Pty Limited
Study Sponsor  ICMJE Mimetica Pty Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan S Dosik, MD TKL Research, Inc.
PRS Account Mimetica Pty Limited
Verification Date September 2014

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