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"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
NCT04169490 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04169490
The ClinicalTrials.gov registry entry for NCT04169490 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Center for Clinical and Cosmetic Research, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04169490 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04169490?
This trial is sponsored by The Center for Clinical and Cosmetic Research, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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