ClinicalTrials.gg
Status unknownNCT02395549Updated Jun 16, 2016

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

A Phase 2 interventional study of 0.375% (w/w) MTC896 Gel and 0.75% (w/w) MTC896 Gel in Acne Vulgaris, sponsored by Mimetica Pty Limited. Status unknown at 20 sites in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by Mimetica Pty Limited · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
364
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 364 is above the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Mimetica Pty Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Is a male or nonpregnant, non-lactating, non-breastfeeding female, 16 to 65 years of age, inclusive, at the time of screening;
  2. 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);
  3. 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;
  4. Is willing to comply with the requirements of the protocol;
  5. 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);
  6. 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;
  7. 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;
  8. 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;
  9. 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);
  10. 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;
  11. 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;
  12. Is willing to refrain from using any treatments, other than the study medication, including antibiotics, for acne present on the face. Topical acne treatments that do not have significant or measurable systemic absorption (e.g. benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders, and chest only.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Pregnant or lactating or plan to become pregnant within 1 month (30 days) of study completion;
  3. Known allergy/sensitivity to any of the study medication components;
  4. 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);
  5. Excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris;
  6. Excessive sun exposure, in the opinion of the Investigator, or use of tanning booths;
  7. Active cystic acne or acne conglobata, acne fulminans, and secondary acne;
  8. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator;
  9. Participation in an investigational drug study within 30 days prior to Screening;
  10. Is a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the Investigator;
  11. Any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study;
  12. Within 9 months (270 days) prior to Baseline and throughout the study:

    - Oral retinoid use (e.g. isotretinoin);

  13. Within 6 months (180 days) prior to Baseline and throughout the study:

    - Treatment with Vitamin A supplements greater than 10,000 units/day;

  14. Within 3 months (90 days) prior to Baseline and throughout the study:

    • Use of androgen receptor blockers (such as spironolactone or flutamide);
    • Initiation of treatment with hormonal therapy or dose change to hormonal therapy;
    • Dose and frequency of use of any hormonal therapy started more than 3 months (90 days) prior to Baseline must remain unchanged throughout the study;
    • Hormonal therapies include, but are not limited to, testosterone, anabolic steroids, birth control pills;
  15. Within 8 weeks (56 days) prior to Baseline and throughout the study:

    - Facial procedures (chemical or laser peel, microdermabrasion, etc.);

  16. Within 4 weeks (28 days) prior to Baseline and throughout the study:

    • Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids);
    • Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs; Note: Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis and if not used consecutively for >14 days prior to Baseline is acceptable and does not require washout. Low dose (81 mg) aspirin taken daily is acceptable.
    • Prescription topical retinoid use on the face (e.g. tretinoin, tazarotene, adapalene);
    • Antifungals, antiretrovirals and antibiotics included in the CYP 3A4 and CYP 3A5;
  17. Within 2 weeks (14 days) prior to Baseline and throughout the study:

    • Treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide);
    • Treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face;
  18. Within 1 day prior to Baseline and throughout the study:

    • Grapefruit juice which is included in the CYP 3A4 and CYP 3A5.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
364 participants (actual)

Study arms

  • Experimental
    0.375% (w/w) MTC896 Gel

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

    Drug: 0.375% (w/w) MTC896 Gel

  • Experimental
    0.75% (w/w) MTC896 Gel

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

    Drug: 0.75% (w/w) MTC896 Gel

  • Experimental
    1.5% (w/w) MTC896 Gel

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

    Drug: 1.5% (w/w) MTC896 Gel

  • Placebo comparator
    Vehicle Control Gel

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

    Drug: Vehicle Control Gel

Interventions

  • Drug0.375% (w/w) MTC896 Gel

    0.375% (w/w) MTC896 Gel

  • Drug0.75% (w/w) MTC896 Gel

    0.75% (w/w) MTC896 Gel

  • Drug1.5% (w/w) MTC896 Gel

    1.5% (w/w) MTC896 Gel

  • DrugVehicle Control Gel
06

What researchers measure

Primary outcomes

  1. Absolute change from baseline in inflammatory lesion counts

    Time frame: Week 12

  2. Absolute change from baseline in noninflammatory lesion counts

    Time frame: Week 12

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

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

    Time frame: Week 12

Secondary outcomes

  1. Percent change from baseline in inflammatory lesion counts

    Time frame: Weeks 4, 8 and 12

  2. Percent change from baseline in noninflammatory lesion counts

    Time frame: Weeks 4, 8 and 12

  3. Percent change from baseline in total lesion counts

    Time frame: Weeks 4, 8 and 12

  4. Absolute change from baseline in inflammatory lesion counts

    Time frame: Weeks 4 and 8

  5. Absolute change from baseline in noninflammatory lesion counts

    Time frame: Weeks 4 and 8

  6. Absolute change from baseline in total lesion counts

    Time frame: Weeks 4, 8 and 12

  7. Proportion of subjects with IGA success

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

    Time frame: Weeks 4 and 8

  8. Time to IGA success

    Time frame: Week 12

  9. Proportion of subjects who achieved at least a 2 grade reduction and an IGA score of clear or almost clear

    Time frame: Weeks 4, 8 and 12

  10. Proportion of subjects who achieved a "Clear" or "Almost Clear" IGA score

    Time frame: Weeks 4, 8 and 12

07

Study locations

20 sites
  • Sacramento, California, United States
  • San Diego, California 92108, United States
  • San Diego, California 92123, United States
  • Denver, Colorado, United States
  • Sanford, Florida, United States
  • West Palm Beach, Florida, United States
  • Louisville, Kentucky, United States
  • Warren, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Albuquerque, New Mexico, United States
  • High Point, North Carolina, United States
  • Hershey, Pennsylvania, United States
  • Johnston, Rhode Island, United States
  • Warwick, Rhode Island, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • College Station, Texas, United States
  • Plano, Texas, United States
  • Salt Lake City, Utah, United States
  • Spokane, Washington, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02395549
Lead sponsor
Mimetica Pty Limited
Responsible party
Sponsor
First posted
Mar 23, 2015
Start date
Apr 2015
Primary completion
Jun 2016
Completion
Aug 2016 (estimated)
Last update
Jun 16, 2016

Study contacts

Debra Dow
study director · Symbio, LLC
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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