Phase 4
N=30
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Keloid · Hypertrophic Scar · Cicatrix, Hypertrophic
Bottom Line
View on ClinicalTrials.gov: NCT00754247 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change in Lesion Volume — 40; 42; 32 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0.5% hydrocortisone, silicone, vitamin E lotion (Drug); Onion extract gel (Drug); Cetearyl alcohol lotion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lesion Volume |
40; 42; 32 | — |
| SECONDARY Change in Lesion Length |
12; 13; 3 | — |
| SECONDARY Change in Lesion Width |
0; 16; 5 | — |
| SECONDARY Change in Lesion Induration |
68; 50; 2 | — |
| SECONDARY Change in Lesion Erythema |
72; 8; 1 | — |
| SECONDARY Change in Lesion Pigmentary Alteration |
61; 30; 0 | — |
| SECONDARY Change in Lesion Cosmetic Appearance |
48; 20; 58 | — |
| SECONDARY Change in Lesion Cosmetic Appearance |
48; 20; 58 | — |
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.
Eligibility Criteria
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Male or female, at least 18 years old in good general health, that have a hypertrophic and keloid scar. The length of the scar should be between 1-4 cm. Individuals who are willing and able to follow the requirements for study participation
- The investigator believes that the scar could benefit from the study medication.
Exclusion Criteria
Subjects who meet any of the following criteria should be excluded from the study:
- Individuals with target scar that is not amenable to the randomized treatment
- Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy test during the duration of the study, or breast-feeding an infant
- Individuals with uncontrolled diabetes or autoimmune disorders
- Individuals who have received scar treatment within one month of the first day of study treatment
- Individuals who plan to receive scar treatment(s) other than study treatment during the trial
- Individuals with a known sensitivity to any ingredients in the test products
- Individuals with any skin conditions or taking any medications that may interfere with the study medication.
Data sourced from ClinicalTrials.gov (NCT00754247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.