A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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 |
|---|---|
|
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 Name: 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 Name: 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 Name: Cetaphil lotion
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00754247
| United States, Florida | |
| University of Miami Skin Research Group Office | |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: | Brian Berman, M.D., Ph.D | University of Miami, Department of Dermatology and Cutaneous Surgery |
More Information
Additional Information:
Publications:
| Responsible Party: | Brian Berman, M.D., Ph.D., University of Miami Miller School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00754247 History of Changes |
| Other Study ID Numbers: | 20060131 |
| Study First Received: | September 15, 2008 |
| Last Updated: | October 18, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Cicatrix, Hypertrophic Hypertrophy Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Anatomical Alpha-Tocopherol Cortisol succinate Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone-17-butyrate |
Tocopherols Tocotrienols Vitamin E Vitamins Anti-Inflammatory Agents Antioxidants Dermatologic Agents Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015