Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.

Detailed Description
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Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation. Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.

Official Title
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Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery

Conditions
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Hypertrophic Scars

Intervention / Treatment
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* Drug: 0.05% Clobetasol propionate
* Drug: Petrolatum gel
* Device: Fractional Erbium:Yag (2,940-nm) laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects with age range 18-60 years; Subject with hypertrophic scar from abdominal surgery for at least 3 months; Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months Exclusion Criteria: Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area; Subject who smoke cigarette; Subject who was treated with Intralesional corticosteroid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser+Topical corticosteroid<br>Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side | Drug: 0.05% Clobetasol propionate<br>* 0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions<br>Device: Fractional Erbium:Yag (2,940-nm) laser<br>* The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions<br>|
| Placebo Comparator: Laser+Petrolatum gel<br>Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side | Drug: Petrolatum gel<br>* Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions<br>Device: Fractional Erbium:Yag (2,940-nm) laser<br>* The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar thickness measured by digital calliper |  | change from baseline in scar thickness at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and observer scar assessment scale |  | Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional laser, hypertrophic scar, topical corticosteroid, laser assisted delivery systems