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NCT02815267 · ClinicalTrials.gov registry record · Phase 3

A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

A Phase 3 study, sponsored by Vyne Therapeutics.

Completed
Registry status
Phase 3
Development phase
466
Enrollment target

NCT02815267: Completed Phase 3 study, sponsored by Vyne Therapeutics.

NCT02815267 is a Phase 3 study that has completed, run by Vyne Therapeutics. The registered enrollment target is 466 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02815267, a Phase 3 study, has completed, sponsored by Vyne Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
466 participants
Enrollment target

Study Summary

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Primary Outcome

To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

Interventions

  • DRUG Vehicle Foam
  • DRUG FMX-101, 4% minocycline foam

Trial Details

FieldValue
Enrollment Target 466 participants
Start Date 2016-05
Est. Completion 2017-10-13
Phase Phase 3
Vyne Therapeutics

18 total trials

What the finished NCT02815267 record still lists

NCT02815267 is an interventional study that assigns participants to a tested intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Vehicle Foam is the first listed.

NCT02815267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02815267 about?

NCT02815267 is a clinical study titled "A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne". This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

What is the current status of trial NCT02815267?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2016-05. Estimated completion is 2017-10-13.

What interventions are being tested in trial NCT02815267?

The interventions under investigation include: Vehicle Foam (DRUG), FMX-101, 4% minocycline foam (DRUG).

Who is sponsoring clinical trial NCT02815267?

This trial is sponsored by Vyne Therapeutics, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02815267's enrollment target sits among peer trials

466 816th of 2000 higher than 1,182 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02815267, the US trial registry maintained by the National Library of Medicine. NCT02815267 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.