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NCT03402893 · ClinicalTrials.gov registry record · Phase 4
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
A Phase 4 study of Acne Vulgaris and Post-inflammatory Hyperpigmentation, sponsored by Derm Research, P.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03402893: Completed Phase 4 study of Acne Vulgaris and Post-inflammatory Hyperpigmentation, sponsored by Derm Research, P.
NCT03402893 is a Phase 4 study of Acne Vulgaris and Post-inflammatory Hyperpigmentation that has completed, run by Derm Research, P. The registered enrollment target is 21 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03402893, a Phase 4 study of Acne Vulgaris and Post-inflammatory Hyperpigmentation, has completed, sponsored by Derm Research, P.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.
Primary Outcome
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Conditions Studied
Interventions
- DRUG ONEXTON Topical Gel
Study Locations (1)
Kentucky
- DermResearch, PLLC - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-07-28 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 4 |
What the finished NCT03402893 record still lists
NCT03402893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which ONEXTON Topical Gel is the first listed.
NCT03402893 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03402893 about?
NCT03402893 is a clinical study titled "The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color". This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessm...
What is the current status of trial NCT03402893?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2017-07-28. Estimated completion is 2018-02-28.
What conditions does trial NCT03402893 study?
This clinical trial studies the following conditions: Acne Vulgaris, Post-inflammatory Hyperpigmentation.
What interventions are being tested in trial NCT03402893?
The interventions under investigation include: ONEXTON Topical Gel (DRUG).
Who is sponsoring clinical trial NCT03402893?
This trial is sponsored by Derm Research, P, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03402893 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03402893's enrollment target sits among peer trials
21 61st of 67 higher than 7 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.
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