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NCT01313728 · ClinicalTrials.gov registry record · Phase 4

A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

A Phase 4 study of Acne Vulgaris, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 4
Development phase
26
Enrollment target
1
Study location

NCT01313728: Completed Phase 4 study of Acne Vulgaris, sponsored by Bausch Health Americas.

NCT01313728 is a Phase 4 study of Acne Vulgaris that has completed, run by Bausch Health Americas. The registered enrollment target is 26 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01313728, a Phase 4 study of Acne Vulgaris, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 4
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.

Primary Outcome

Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).

Conditions Studied

Interventions

  • DRUG Dapsone plus Tretinoin Gel
  • DRUG Tretinoin Gel

Study Locations (1)

Pennsylvania

  • Skin Study Center - Broomall

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-12
Est. Completion 2011-01
Phase Phase 4
Bausch Health Americas

168 total trials

What the finished NCT01313728 record still lists

NCT01313728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Dapsone plus Tretinoin Gel is the first listed.

NCT01313728 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01313728 about?

NCT01313728 is a clinical study titled "A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products". This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to th...

What is the current status of trial NCT01313728?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2010-12. Estimated completion is 2011-01.

What conditions does trial NCT01313728 study?

This clinical trial studies the following conditions: Acne Vulgaris.

What interventions are being tested in trial NCT01313728?

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

Who is sponsoring clinical trial NCT01313728?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01313728 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acne Vulgaris

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01313728's enrollment target sits among peer trials

26 57th of 67 higher than 9 of 67 other Acne Vulgaris trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acne Vulgaris 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 NCT01313728, the US trial registry maintained by the National Library of Medicine. NCT01313728 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.