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NCT00754247 · ClinicalTrials.gov registry record · Phase 4
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
A Phase 4 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00754247: Completed Phase 4 study, sponsored by University of Miami.
NCT00754247 is a Phase 4 study that has completed, run by University of Miami. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00754247, a Phase 4 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.
Primary Outcome
Blinded investigator assessed the scar volume by using an alginate impression.
Interventions
- DRUG 0.5% hydrocortisone, silicone, vitamin E lotion
- DRUG Onion extract gel
- DRUG Cetearyl alcohol lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00754247 record still lists
NCT00754247 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which 0.5% hydrocortisone, silicone, vitamin E lotion is the first listed.
NCT00754247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00754247 about?
NCT00754247 is a clinical study titled "A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars". Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5...
What is the current status of trial NCT00754247?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2006-03. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00754247?
The interventions under investigation include: 0.5% hydrocortisone, silicone, vitamin E lotion (DRUG), Onion extract gel (DRUG), Cetearyl alcohol lotion (DRUG).
Who is sponsoring clinical trial NCT00754247?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00754247's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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