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
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.
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 →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.
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.
Has been diagnosed with mild-to-severe acne vulgaris defined as:
Exclusion Criteria:
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;
Within 3 months (90 days) prior to Baseline and throughout the study:
Within 8 weeks (56 days) prior to Baseline and throughout the study:
- Facial procedures (chemical or laser peel, microdermabrasion, etc.);
Within 4 weeks (28 days) prior to Baseline and throughout the study:
Within 2 weeks (14 days) prior to Baseline and throughout the study:
Within 1 day prior to Baseline and throughout the study:
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 will be applied bid to the whole face for 12 weeks.
Drug: 0.75% (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
Vehicle Control Gel will be applied bid to the whole face for 12 weeks.
Drug: Vehicle Control Gel
0.375% (w/w) MTC896 Gel
0.75% (w/w) MTC896 Gel
1.5% (w/w) MTC896 Gel
Absolute change from baseline in inflammatory lesion counts
Time frame: Week 12
Absolute change from baseline in noninflammatory lesion counts
Time frame: Week 12
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
Percent change from baseline in inflammatory lesion counts
Time frame: Weeks 4, 8 and 12
Percent change from baseline in noninflammatory lesion counts
Time frame: Weeks 4, 8 and 12
Percent change from baseline in total lesion counts
Time frame: Weeks 4, 8 and 12
Absolute change from baseline in inflammatory lesion counts
Time frame: Weeks 4 and 8
Absolute change from baseline in noninflammatory lesion counts
Time frame: Weeks 4 and 8
Absolute change from baseline in total lesion counts
Time frame: Weeks 4, 8 and 12
Proportion of subjects with IGA success
i.e. who achieved a minimum 2-grade improvement from baseline
Time frame: Weeks 4 and 8
Time to IGA success
Time frame: Week 12
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
Proportion of subjects who achieved a "Clear" or "Almost Clear" IGA score
Time frame: Weeks 4, 8 and 12
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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