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NCT01797432 · ClinicalTrials.gov registry record · Phase 2
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01797432: Completed Phase 2 study, sponsored by University of Minnesota.
NCT01797432 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797432, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.
Primary Outcome
The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Lef
Interventions
- DEVICE Restylane
- DRUG Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01797432 record still lists
NCT01797432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Restylane is the first listed.
NCT01797432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01797432 about?
NCT01797432 is a clinical study titled "Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata". The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promotin...
What is the current status of trial NCT01797432?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01797432?
The interventions under investigation include: Restylane (DEVICE), Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (DRUG).
Who is sponsoring clinical trial NCT01797432?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01797432's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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