Clinical trial NCT00754247: A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keloid
Hypertrophic Scar
Cicatrix, Hypertrophic
Keywords: Keloid
Hypertrophic scar
Hydrocortisone, silicone, vitamin E lotion
HSE
Onion extract gel
OE
Cetearyl alcohol lotion
CEA
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: Change in Lesion Volume
timeFrame: Assessed at Baseline visit (week 0) and week 16
Secondary outcomes:
measure: Change in Lesion Length
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Width
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Induration
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Erythema
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Pigmentary Alteration
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Cosmetic Appearance
timeFrame: Assessed at Baseline visit (week 0) and week 16
measure: Change in Lesion Cosmetic Appearance
timeFrame: Assessed at Baseline visit (week 0) and week 16
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Skin Research Group Office
state: Florida
Study officials:
affiliation: University of Miami, Department of Dermatology and Cutaneous Surgery
name: Brian Berman, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Augusti KT. Therapeutic values of onion (Allium cepa L.) and garlic (Allium sativum L.). Indian J Exp Biol. 1996 Jul;34(7):634-40.
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. doi: 10.1097/00006534-200207000-00029.
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. doi: 10.1097/00004630-200205000-00010.
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. doi: 10.1111/j.1524-4725.1996.tb00728.x.
citation: Eisen D. A pilot study to evaluate the efficacy of scarguard in the prevention of scars. Internet J Dermatol. 2004;5.
citation: 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.
citation: 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.
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. doi: 10.1111/j.1524-4725.2006.32045.x.