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NCT04169490
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
NA trial testing Placebo Cream Base Emulsion Moisturizer in Scar in 75 participants. Completed in 3 November 2020.
4 September 2020
Quick facts
| Lead sponsor | The Center for Clinical and Cosmetic Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 7 February 2019 |
| Primary completion | 4 September 2020 |
| Estimated completion | 3 November 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo Cream Base Emulsion Moisturizer
- FS2 Emulsion Moisturizer
- Active Comparator Onion Skin Extract Gel (Mederma)
- Active Comparator Silicone Gel (Kelo-Cote)
- Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer
Conditions studied
- Scar — all drugs for Scar →
- Keloid — all drugs for Keloid →
- Hypertrophic Scar — all drugs for Hypertrophic Scar →
- Cicatrix — all drugs for Cicatrix →
Sponsor
The Center for Clinical and Cosmetic Research
Who can join
18 and older, any sex, with Scar or Keloid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov.
Park S, Li D, Guo L, Xu X. · · 2026 · PMID 42077711 · DOI 10.7759/cureus.106243
Verify or expand the search:
- PubMed search for NCT04169490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other The Center for Clinical and Cosmetic Research trials
Trials by the same sponsor.
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- NCT05239429 — Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique · NA · completed
- NCT04169438 — Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions · NA · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04169490 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Center for Clinical and Cosmetic Research
- Last refreshed: 21 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04169490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing