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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Mimetica Pty Limited.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mimetica Pty Limited
ClinicalTrials.gov Identifier:
NCT01254162
First received: December 2, 2010
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum production on the forehead of healthy male volunteers.


Condition Intervention Phase
Oily Skin
Seborrhea
Drug: MTC896 Gel
Phase 2

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

Further study details as provided by Mimetica Pty Limited:

Primary Outcome Measures:
  • A 20% reduction in sebum production as measured by the Sebumeter [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of the product when applied daily to the forehead for 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: July 2010
Estimated Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo Gel Drug: MTC896 Gel
0.75% w/w gel applied daily for 28 days to the forehead

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01254162

Locations
United States, New Jersey
TKL Research, Inc
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Mimetica Pty Limited
Investigators
Principal Investigator: Jonathan S Dosik, MD TKL Research, Inc.
  More Information

No publications provided

Responsible Party: Dr Michael Thurn, Mimetica Pty Limited
ClinicalTrials.gov Identifier: NCT01254162     History of Changes
Other Study ID Numbers: MCL10001
Study First Received: December 2, 2010
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mimetica Pty Limited:
Oily Skin
Sebum

Additional relevant MeSH terms:
Dermatitis, Seborrheic
Dermatitis
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 19, 2014