A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars - Full Text View

Sponsored by:	University of Miami
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00754247

Purpose

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.

Condition	Intervention	Phase
Keloid Hypertrophic Scar Cicatrix, Hypertrophic	Drug: 0.5% hydrocortisone, silicone, vitamin E lotion Drug: Onion extract gel Drug: Cetearyl alcohol lotion	Phase IV

MedlinePlus related topics: Scars

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Miami:

Primary Outcome Measures:

Assessment of target scar by investigator (size, color, firmness, symptoms such as tenderness, pain, and itching) [ Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Volume changes [ Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
Color changes [ Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Regimen A: Experimental 0.5% hydrocortisone, silicone, vitamin E lotion	Drug: 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: Experimental Onion extract gel	Drug: 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: Placebo Comparator Cetearyl alcohol lotion	Drug: 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.

Detailed Description:

This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit, Week 4, 8, 12, and 16 ), excluding the Screening Visit.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754247

Locations

United States, Florida
University of Miami Skin Research Group Office
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator:

Brian Berman, M.D., Ph.D

University of Miami, Department of Dermatology and Cutaneous Surgery

More Information

Skin Research Group Website This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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. 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.

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.

Responsible Party:	University of Miami Miller School of Medicine ( Brian Berman, M.D., Ph.D. )
Study ID Numbers:	20060131
Study First Received:	September 15, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00754247
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Keloid
Hypertrophic scar
Hydrocortisone, silicone, vitamin E lotion
HSE

Onion extract gel
OE
Cetearyl alcohol lotion
CEA

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Tocopherol acetate
Hydrocortisone
Cortisol succinate
Collagen Diseases
Skin Diseases
Keloid
Alpha-Tocopherol

Tocopherols
Hypertrophy
Vitamin E
Cicatrix, Hypertrophic
Connective Tissue Diseases
Hydrocortisone acetate
Cicatrix
Ethanol

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Therapeutic Uses
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009