A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
NCT ID: NCT00754247
Last Updated: 2019-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2006-03-31
2008-02-29
Brief Summary
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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.
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Detailed Description
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Screening Visit/Baseline Visit:
Patients will read and be explained the informed consent. Patients who agree to participate will sign the informed consent and a copy will be given to them. Medical history and exclusion/inclusion criteria will be reviewed; if a patient qualifies he/she will be assigned a randomization number for the treatment.
At the baseline visit, medical history and exclusion/inclusion criteria since the screening visit will be reviewed. Patients randomized to the HSE group will receive one tube and apply the first application to the keloid/hypertrophic scar during the baseline visit. Patients randomized to the OE group will be given a tube of OE gel and will apply the first application to the keloid/hypertrophic scar. Patients in the placebo group will be given a bottle of CEA lotion, the placebo medication, and will apply the first application to the keloid/hypertrophic scar. The medications will be given by the unblinded investigator and the blinded investigator will be evaluating the patients. Photographs of the patient's keloid/hypertrophic scar will be taken, and the keloid/hypertrophic scar will be measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy test will be obtained for all women of child-bearing potential.
Week 4, 8, 12, and 16 Visit:
Patients will be asked about side effects since last visit. Photographs of the patient's keloid/hypertrophic scar will be taken and the keloid/hypertrophic scar will be measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy test will be obtained at for all women of child-bearing potential.
Methods of Study Lesion Assessment
A. Volume B. Linear dimensions
Investigator's Assessments w/ Visual Analog Scale (VAS):
C. Cosmetic assessment D. Induration (hardness) \[compared to standardized hard discs with numerical ranking of increased induration\] E. Erythema (redness) F. Pigmentary alteration
Patient's Assessments w/ VAS:
G. Cosmetic assessment H. Pain I. Tenderness J. Pruritus (itching) K. Patient satisfaction
L. Digital photographs
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Regimen A
0.5% hydrocortisone, silicone, vitamin E lotion
0.5% hydrocortisone, silicone, vitamin E lotion
0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing.
Regimen B
Onion extract gel
Onion extract gel
Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
Regimen C
Cetearyl alcohol lotion
Cetearyl alcohol lotion
Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion.
Interventions
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0.5% hydrocortisone, silicone, vitamin E lotion
0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing.
Onion extract gel
Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.
Cetearyl alcohol lotion
Placebo is cetearyl alcohol lotion with no steroids, silicone, vitamin E, or onion extract and will be applied 2 times a day to the lesion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The investigator believes that the scar could benefit from the study medication.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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University of Miami
OTHER
Responsible Party
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Robert S. Kirsner
Professor
Principal Investigators
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Brian Berman, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Miami, Department of Dermatology and Cutaneous Surgery
Locations
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University of Miami Skin Research Group Office
Miami, Florida, United States
Countries
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References
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Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40.
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. doi: 10.1097/00006534-200207000-00029.
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. doi: 10.1097/00004630-200205000-00010.
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. doi: 10.1111/j.1524-4725.1996.tb00728.x.
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. doi: 10.1046/j.1524-475x.2003.11313.x. No abstract available.
Jackson BA, Shelton AJ. Pilot study evaluating topical onion extract as treatment for postsurgical scars. Dermatol Surg. 1999 Apr;25(4):267-9. doi: 10.1046/j.1524-4725.1999.08240.x.
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. doi: 10.1111/j.1524-4725.2006.32045.x.
Related Links
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Skin Research Group Website
Other Identifiers
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20060131
Identifier Type: -
Identifier Source: org_study_id
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