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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scars
• Intervention / Treatment: Drug: 0.05% Clobetasol propionate; Device: Fractional Erbium:Yag (2,940-nm) laser; Drug: Petrolatum gel

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laser+Topical corticosteroid; 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; 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; Device: Fractional Erbium:Yag (2,940-nm) laser; 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
Placebo Comparator: Laser+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	Device: Fractional Erbium:Yag (2,940-nm) laser; 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; Drug: Petrolatum gel; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: hypertrophic scar; fractional laser; topical corticosteroid; laser assisted delivery systems
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Emollients; Clobetasol; Petrolatum
• Other Study ID Numbers: 614/2556 (EC2)