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

NCT01254162 | Completed Phase 2 DMC

• 1 other identifier: MCL10001
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Oily Skin; Seborrhea

Keywords

Oily Skin; Sebum

Outcome Measures

Primary Outcomes (1)

• A 20% reduction in sebum production as measured by the Sebumeter

  28 days

Secondary Outcomes (1)

• Assess the safety and tolerability of the product when applied daily to the forehead for 28 days

  28 days

Study Arms (1)

Placebo Gel

EXPERIMENTAL

Drug: MTC896 Gel

Interventions

MTC896 Gel DRUG

0.75% w/w gel applied daily for 28 days to the forehead

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Are healthy males;
• \. Are between 18 and 65 years of age;
• \. Have self-perceived oily skin confirmed by a clinical assessment;
• \. Have an average Sebumeter® reading of ≥ 220 µg/cm2 on the forehead;
• \. Have a negative urine drug screening test result;
• \. Have a negative HIV and hepatitis screening test result;
• \. Agree to use adequate contraceptive precautions (ie, use of condoms) during the conduct of the study;
• \. Have a body mass index (BMI) of 19 to 34 kg/m2;
• \. 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;
• \. 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;
• \. Are willing to avoid sun exposure and to protect the forehead with a hat/visor;
• \. Are fluent in the English language;
• \. Complete a standard Medical Screening form as well as a Medical Personal History form; and
• \. Read, understand, and provide a signed informed consent.

You may not qualify if:

• \. Have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the study evaluations;
• \. Have a history of photosensitive reactions or a history of cutaneous or systemic lupus or other disorders frequently associated with photosensitivity;
• \. 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);
• \. 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;
• \. 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;
• \. Are using any medication which, in the opinion of the investigator, will interfere with the study evaluations;
• \. Have seborrheic dermatitis and/or active atopic dermatitis/eczema in or around the test sites;
• \. Have a known allergy and/or hypersensitivity to constituents present in the study products;
• \. 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;
• \. Have received treatment for any type of internal cancer within 5 years prior to study enrollment;
• \. Have a history of, or are currently being treated for skin cancer;
• \. Are currently participating in any clinical testing; and/or
• \. Have received any investigational treatment(s) within 4 weeks prior to study enrollment.

Sponsors & Collaborators

• Mimetica Pty Limited: lead

Study Sites (1)

TKL Research, Inc

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Jonathan S Dosik, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (1)