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NCT03689452 · ClinicalTrials.gov registry record · NA
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
A NA study of Androgenetic Alopecia and Alopecia, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03689452: Completed NA study of Androgenetic Alopecia and Alopecia, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03689452 is a NA study of Androgenetic Alopecia and Alopecia that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants, below the 163-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689452, a NA study of Androgenetic Alopecia and Alopecia, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared. In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.
Primary Outcome
Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II
Conditions Studied
Interventions
- DEVICE Platelet Rich Plasma
- DRUG Normal saline
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-06-03 |
| Phase | NA |
What the finished NCT03689452 record still lists
NCT03689452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 163-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Androgenetic Alopecia appearing as the primary indexed condition, and to 2 interventions - of which Platelet Rich Plasma is the first listed.
NCT03689452 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03689452 about?
NCT03689452 is a clinical study titled "The Effect of Platelet Rich Plasma on Non-scarring Alopecia". The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or in...
What is the current status of trial NCT03689452?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2018-10-01. Estimated completion is 2019-06-03.
What conditions does trial NCT03689452 study?
This clinical trial studies the following conditions: Androgenetic Alopecia, Alopecia.
What interventions are being tested in trial NCT03689452?
The interventions under investigation include: Platelet Rich Plasma (DEVICE), Normal saline (DRUG).
Who is sponsoring clinical trial NCT03689452?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03689452 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03689452's enrollment target sits among peer trials
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