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

June 17, 2019 updated by: Robert S. Kirsner, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen A
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.
Other Names:
  • Scarguard
Experimental: Regimen B
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.
Other Names:
  • Mederma
Placebo Comparator: Regimen C
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.
Other Names:
  • Cetaphil lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lesion Volume
Time Frame: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar volume by using an alginate impression.
Assessed at Baseline visit (week 0) and week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lesion Length
Time Frame: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.
Assessed at Baseline visit (week 0) and week 16
Change in Lesion Width
Time Frame: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width.
Assessed at Baseline visit (week 0) and week 16
Change in Lesion Induration
Time Frame: Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.
Assessed at Baseline visit (week 0) and week 16
Change in Lesion Erythema
Time Frame: 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).
Assessed at Baseline visit (week 0) and week 16
Change in Lesion Pigmentary Alteration
Time Frame: 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).
Assessed at Baseline visit (week 0) and week 16
Change in Lesion Cosmetic Appearance
Time Frame: Assessed at Baseline visit (week 0) and week 16
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
Change in Lesion Cosmetic Appearance
Time Frame: 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).
Assessed at Baseline visit (week 0) and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Brian Berman, M.D., Ph.D, University of Miami, Department of Dermatology and Cutaneous Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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