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

Phase 4

Completed

Conditions: Cicatrix, Hypertrophic
Keloid
Hypertrophic Scar

Interventions: Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
Drug: Onion extract gel
Drug: Cetearyl alcohol lotion

Registration Number: NCT00754247

Lead Sponsor: University of Miami

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen A	0.5% hydrocortisone, silicone, vitamin E lotion	0.5% hydrocortisone, silicone, vitamin E lotion
Regimen B	Onion extract gel	Onion extract gel
Regimen C	Cetearyl alcohol lotion	Cetearyl alcohol lotion

Primary Outcome Measures

Name	Time	Method
Change in Lesion Volume	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar volume by using an alginate impression.

Secondary Outcome Measures

Name	Time	Method
Change in Lesion Length	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
Change in Lesion Induration	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.
Change in Lesion Cosmetic Appearance	Assessed at Baseline visit (week 0) and week 16	Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Change in Lesion Erythema	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Change in Lesion Pigmentary Alteration	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0-100 (0=best and 100=worst).
Change in Lesion Width	Assessed at Baseline visit (week 0) and week 16	Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width.