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NCT04169490 · ClinicalTrials.gov registry record · NA
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
A NA study of Scar and Keloid, sponsored by The Center for Clinical and Cosmetic Research.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT04169490: Completed NA study of Scar and Keloid, sponsored by The Center for Clinical and Cosmetic Research.
NCT04169490 is a NA study of Scar and Keloid that has completed, run by The Center for Clinical and Cosmetic Research. The registered enrollment target is 75 participants, above the 44-participant average among 15 other Scar trials with a reported enrollment target (70% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169490, a NA study of Scar and Keloid, has completed, sponsored by The Center for Clinical and Cosmetic Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase II prospective, randomized, double-blind, placebo controlled and comparative clinical study evaluating hydrogel scar-management modalities for effective management of hyperproliferative scars and keloids. This is a double-blinded study, which means that neither the evaluating physician nor the subject will know which treatment is administered. Group selection and assignment will be made at random, with a 2 in 5 chance of receiving a market-approved therapy, and 1 in 5 chance of receiving the placebo. Subjects assigned the placebo-moisturizer will receive a standard hypoallergenic dermatological hydrating cream base. Subjects assigned the silicone gel, will receive a commercially available, active comparator.
Primary Outcome
Investigator assessment of target scar or keloid using the Vancouver Scar Scale (VSS). Scale parameters include: Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), and Height (0-3). Scale measurements include: minimum score of 0 = normal to a maximum score of 2, 3 or 5 depending on the parameter measured.
Conditions Studied
Interventions
- OTHER Placebo Cream Base Emulsion Moisturizer
- OTHER FS2 Emulsion Moisturizer
- OTHER Active Comparator Onion Skin Extract Gel (Mederma)
- OTHER Active Comparator Silicone Gel (Kelo-Cote)
- OTHER Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer
Study Locations (1)
Florida
- The Center for Clinical and Cosmetic Research - Aventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2020-11-03 |
| Phase | NA |
What the finished NCT04169490 record still lists
NCT04169490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 44-participant average among 15 other Scar trials with a reported enrollment target (70% higher).
The record links to 4 conditions, with Scar appearing as the primary indexed condition, and to 5 interventions - of which Placebo Cream Base Emulsion Moisturizer is the first listed.
NCT04169490 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04169490 about?
NCT04169490 is a clinical study titled ""A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"". A Phase II prospective, randomized, double-blind, placebo controlled and comparative clinical study evaluating hydrogel scar-management modalities for effective management of hyperproliferative scars and keloids. This is a double-blinded study, which means that neither the evaluating physician nor ...
What is the current status of trial NCT04169490?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2019-02-07. Estimated completion is 2020-11-03.
What conditions does trial NCT04169490 study?
This clinical trial studies the following conditions: Scar, Keloid, Hypertrophic Scar, Cicatrix.
What interventions are being tested in trial NCT04169490?
The interventions under investigation include: Placebo Cream Base Emulsion Moisturizer (OTHER), FS2 Emulsion Moisturizer (OTHER), Active Comparator Onion Skin Extract Gel (Mederma) (OTHER), Active Comparator Silicone Gel (Kelo-Cote) (OTHER), Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer (OTHER).
Who is sponsoring clinical trial NCT04169490?
This trial is sponsored by The Center for Clinical and Cosmetic Research, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169490 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Scar
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 NCT04169490's enrollment target sits among peer trials
75 3rd of 15 higher than 13 of 15 other Scar trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scar 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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