A Study to Determine the Efficacy of Topically Applied MTC896 Gel in Subjects With Acne Vulgaris

NCT02395549 | Unknown Phase 2

• 1 other identifier: MCL15001
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 20

Brief Summary

This study is designed to investigate the efficacy, safety and tolerability of MTC896 Gel in subjects with acne. In this study, MTC896 Gel will be applied at 3 concentrations, twice daily (bid) for 12 weeks and compared against a vehicle control.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Absolute change from baseline in inflammatory lesion counts

  Week 12

• Absolute change from baseline in noninflammatory lesion counts

  Week 12

• Proportion of subjects with Investigator"s Global Assessment (IGA) success

  i.e., who achieved a minimum 2-grade improvement from baseline

  Week 12

Secondary Outcomes (10)

• Percent change from baseline in inflammatory lesion counts

  Weeks 4, 8 and 12

• Percent change from baseline in noninflammatory lesion counts

  Weeks 4, 8 and 12

• Percent change from baseline in total lesion counts

  Weeks 4, 8 and 12

• Absolute change from baseline in inflammatory lesion counts

  Weeks 4 and 8

• Absolute change from baseline in noninflammatory lesion counts

  Weeks 4 and 8

Study Arms (4)

0.375% (w/w) MTC896 Gel

EXPERIMENTAL

0.375% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.

Drug: 0.375% (w/w) MTC896 Gel

0.75% (w/w) MTC896 Gel

EXPERIMENTAL

0.75% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.

Drug: 0.75% (w/w) MTC896 Gel

1.5% (w/w) MTC896 Gel

EXPERIMENTAL

1.5% (w/w) MTC896 Gel will be applied bid to the whole face for 12 weeks.

Drug: 1.5% (w/w) MTC896 Gel

Vehicle Control Gel

PLACEBO COMPARATOR

Vehicle Control Gel will be applied bid to the whole face for 12 weeks.

Drug: Vehicle Control Gel

Interventions

0.375% (w/w) MTC896 Gel DRUG

0.375% (w/w) MTC896 Gel

0.375% (w/w) MTC896 Gel

0.75% (w/w) MTC896 Gel DRUG

0.75% (w/w) MTC896 Gel

0.75% (w/w) MTC896 Gel

1.5% (w/w) MTC896 Gel DRUG

1.5% (w/w) MTC896 Gel

1.5% (w/w) MTC896 Gel

Vehicle Control Gel DRUG

Vehicle Control Gel

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male or nonpregnant, non-lactating, non-breastfeeding female, 16 to 65 years of age, inclusive, at the time of screening;
• Has provided written informed consent/assent (which includes consent for photographs, if applicable, to be taken at Baseline and end-of-treatment/end-of-study \[EOT/EOS\] visits);
• Has been diagnosed with mild-to-severe acne vulgaris defined as:
• At least 20 inflammatory lesions,
• At least 20 noninflammatory lesions,
• ≤ 2 nodular lesions, and
• Investigator Global Assessment of 2 or greater;
• Is willing to comply with the requirements of the protocol;
• If female and of child-bearing potential or premenarcheal, has a negative urine pregnancy test at Screening and Baseline / Day 1 and is willing to use effective contraception during the study and for 30 days after the last study medication application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), diagnosed as infertile, or are postmenopausal for at least 1 year; (Acceptable methods of birth control are defined as: abstinence, oral contraceptives, contraceptive patches/implants, Depo-Provera®, double barrier methods (e.g. condom and spermicide) or an intrauterine device (IUD). Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation);
• If male, has been vasectomized or agrees to use an accepted method of birth control with female partner during study participation and for 30 days after the last study medication application;
• Is in good health and free from any disease which, in the opinion of the Investigator, would put the subject at risk if participating in the study;
• Is 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;
• Is willing to abstain from using any facial treatment products on the face during the study (continued use of make-up is permitted but may not be changed within 2 weeks prior to the study period or during the entire study period);
• Is willing to avoid sun exposure and to protect the face with a hat/visor; sunscreen use is recommended/allowed when sun exposure cannot be avoided;
• If male, must agree to shave the treatment area and must agree not to alter his routine shaving regimen for the duration of the study;

You may not qualify if:

• People who would otherwise qualify for the study, but are living in the same household as a study subject, are not allowed to participate in the study;
• Pregnant or lactating or plan to become pregnant within 1 month (30 days) of study completion;
• Known allergy/sensitivity to any of the study medication components;
• Any skin condition which may interfere with the evaluation of safety or of acne vulgaris (e.g. rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne or folliculitis);
• Excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris;
• Excessive sun exposure, in the opinion of the Investigator, or use of tanning booths;
• Active cystic acne or acne conglobata, acne fulminans, and secondary acne;
• Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator;
• Participation in an investigational drug study within 30 days prior to Screening;
• Is a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the Investigator;
• Any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study;
• Within 9 months (270 days) prior to Baseline and throughout the study:
• \- Oral retinoid use (e.g. isotretinoin);
• Within 6 months (180 days) prior to Baseline and throughout the study:
• \- Treatment with Vitamin A supplements greater than 10,000 units/day;

Sponsors & Collaborators

• Mimetica Pty Limited: lead

Study Sites (20)

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Sanford, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Warren, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Johnston, Rhode Island, United States

Location

Unknown Facility

Warwick, Rhode Island, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

College Station, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Debra Dow

  Symbio, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

US (20)