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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Hypertrophic Scars

Treatments: Drug: 0.05% Clobetasol propionate; Drug: Petrolatum gel; Device: Fractional Erbium:Yag (2,940-nm) laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02487212

614/2556 (EC2)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Laser+Topical corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: 0.05% Clobetasol propionate

Device: Fractional Erbium:Yag (2,940-nm) laser

Laser+Petrolatum gel

Placebo Comparator group

Description:

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

Treatment:

Device: Fractional Erbium:Yag (2,940-nm) laser

Drug: Petrolatum gel