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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 is a Phase 4 study that has completed, run by University of Miami. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00754247
The ClinicalTrials.gov registry entry for NCT00754247 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 0.5% hydrocortisone, silicone, vitamin E lotion is the first listed.
NCT00754247 reports 0 study locations.
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.
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