Keloid Clinical Trial
Official title:
A Prospective, Randomized, Investigator-blinded, Placebo-controlled, Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
NCT number | NCT00754247 |
Other study ID # | 20060131 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2006 |
Est. completion date | February 2008 |
Verified date | June 2019 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. 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 2. 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: 1. Individuals with target scar that is not amenable to the randomized treatment 2. Individuals who are planning pregnancy, or pregnant as determined by urine pregnancy test during the duration of the study, or breast-feeding an infant 3. Individuals with uncontrolled diabetes or autoimmune disorders 4. Individuals who have received scar treatment within one month of the first day of study treatment 5. Individuals who plan to receive scar treatment(s) other than study treatment during the trial 6. Individuals with a known sensitivity to any ingredients in the test products 7. Individuals with any skin conditions or taking any medications that may interfere with the study medication. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Skin Research Group Office | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40. Review. — View Citation
Chung VQ, Kelley L, Marra D, Jiang SB. Onion extract gel versus petrolatum emollient on new surgical scars: prospective double-blinded study. Dermatol Surg. 2006 Feb;32(2):193-7. — View Citation
Eisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5.
Gilman TH. Silicone sheet for treatment and prevention of hypertrophic scar: a new proposal for the mechanism of efficacy. Wound Repair Regen. 2003 May-Jun;11(3):235-6. — View Citation
Jackson BA, Shelton AJ. Pilot study evaluating topical onion extract as treatment for postsurgical scars. Dermatol Surg. 1999 Apr;25(4):267-9. — View Citation
Musgrave MA, Umraw N, Fish JS, Gomez M, Cartotto RC. The effect of silicone gel sheets on perfusion of hypertrophic burn scars. J Burn Care Rehabil. 2002 May-Jun;23(3):208-14. — View Citation
Phillips TJ, Gerstein AD, Lordan V. A randomized controlled trial of hydrocolloid dressing in the treatment of hypertrophic scars and keloids. Dermatol Surg. 1996 Sep;22(9):775-8. — View Citation
Saulis AS, Mogford JH, Mustoe TA. Effect of Mederma on hypertrophic scarring in the rabbit ear model. Plast Reconstr Surg. 2002 Jul;110(1):177-83; discussion 184-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Lesion Volume | Blinded investigator assessed the scar volume by using an alginate impression. | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Length | Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip. | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Width | Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width. | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Induration | Blinded investigator assessed the scar induration. Measured with a ruler at deepest point. | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Erythema | Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Pigmentary Alteration | Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Cosmetic Appearance | Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 | |
Secondary | Change in Lesion Cosmetic Appearance | Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst). | Assessed at Baseline visit (week 0) and week 16 |
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