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NCT01974323 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

A Phase 3 study, sponsored by Almirall, S.A..

Completed
Registry status
Phase 3
Development phase
2,238
Enrollment target

NCT01974323: Completed Phase 3 study, sponsored by Almirall, S.A..

NCT01974323 is a Phase 3 study that has completed, run by Almirall, S.A.. The registered enrollment target is 2,238 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (190% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01974323, a Phase 3 study, has completed, sponsored by Almirall, S.A..

COMPLETED
Registry status
Phase 3
Development phase
2,238 participants
Enrollment target

Study Summary

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Primary Outcome

The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/

Interventions

  • DRUG Dapsone Gel
  • DRUG Dapsone Gel Vehicle

Trial Details

FieldValue
Enrollment Target 2,238 participants
Start Date 2013-11
Est. Completion 2014-10
Phase Phase 3
Almirall, S.A.

19 total trials

What the finished NCT01974323 record still lists

NCT01974323 is an interventional study that assigns participants to a tested intervention. Its 2,238 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (190% higher).

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

NCT01974323 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01974323 about?

NCT01974323 is a clinical study titled "Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris". This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

What is the current status of trial NCT01974323?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,238 participants. The study started on 2013-11. Estimated completion is 2014-10.

What interventions are being tested in trial NCT01974323?

The interventions under investigation include: Dapsone Gel (DRUG), Dapsone Gel Vehicle (DRUG).

Who is sponsoring clinical trial NCT01974323?

This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01974323's enrollment target sits among peer trials

2,238 95th of 2000 higher than 1,906 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 NCT01974323, the US trial registry maintained by the National Library of Medicine. NCT01974323 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.