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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Keloid, Hypertrophic Scar, Cicatrix, Hypertrophic

Intervention / Treatment
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* Drug: 0.5% hydrocortisone, silicone, vitamin E lotion
* Drug: Onion extract gel
* Drug: Cetearyl alcohol lotion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>0.5% hydrocortisone, silicone, vitamin E lotion | Drug: 0.5% hydrocortisone, silicone, vitamin E lotion<br>* 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.<br>* Other names: Scarguard;|
| Experimental: Regimen B<br>Onion extract gel | Drug: Onion extract gel<br>* Onion extract gel is applied and massaged into the selected scar 3 to 4 times daily according to product instructions for 16 weeks.<br>* Other names: Mederma;|
| Placebo Comparator: Regimen C<br>Cetearyl alcohol lotion | Drug: Cetearyl alcohol lotion<br>* 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.<br>* Other names: Cetaphil lotion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lesion Volume | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloid, Hypertrophic scar, Hydrocortisone, silicone, vitamin E lotion, HSE, Onion extract gel, OE, Cetearyl alcohol lotion, CEA