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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754247
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Robert S. Kirsner, University of Miami

Tracking Information
First Submitted Date  ICMJE September 15, 2008
First Posted Date  ICMJE September 17, 2008
Results First Submitted Date  ICMJE February 18, 2019
Results First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Study Start Date  ICMJE March 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
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 ]
Change History Complete list of historical versions of study NCT00754247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • Volume changes [ Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16 ]
  • Color changes [ Time Frame: Baseline visit (week 0) and weeks 4, 8, 12, 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Keloid
  • Hypertrophic Scar
  • Cicatrix, Hypertrophic
Intervention  ICMJE
  • 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 Name: Scarguard
  • 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 Name: Mederma
  • 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 Name: Cetaphil lotion
Study Arms  ICMJE
  • Experimental: Regimen A
    0.5% hydrocortisone, silicone, vitamin E lotion
    Intervention: Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
  • Experimental: Regimen B
    Onion extract gel
    Intervention: Drug: Onion extract gel
  • Placebo Comparator: Regimen C
    Cetearyl alcohol lotion
    Intervention: Drug: Cetearyl alcohol lotion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2008)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00754247
Other Study ID Numbers  ICMJE 20060131
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert S. Kirsner, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Berman, M.D., Ph.D University of Miami, Department of Dermatology and Cutaneous Surgery
PRS Account University of Miami
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP