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

Phase 4

Completed

• Conditions: Hypertrophic Scars
• Interventions: Drug: Petrolatum gel; Drug: 0.05% Clobetasol propionate

• Registration Number: NCT02487212
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-04
• Study First Submitted: 2015-04-11
• Study Completion: 2015-05
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser+Petrolatum gel	Petrolatum gel	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
Laser+Topical corticosteroid	0.05% Clobetasol propionate	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

Primary Outcome Measures

Name	Time	Method
Scar thickness measured by digital calliper	change from baseline in scar thickness at 6 months

Secondary Outcome Measures

Name	Time	Method
Patient and observer scar assessment scale	Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand