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

NCT02487212 | Completed Phase 4 DMC

• 1 other identifier: 614/2556 (EC2)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scars

Keywords

fractional laser; hypertrophic scar; topical corticosteroid; laser assisted delivery systems

Outcome Measures

Primary Outcomes (1)

• Scar thickness measured by digital calliper

  change from baseline in scar thickness at 6 months

Secondary Outcomes (1)

• Patient and observer scar assessment scale

  Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment

Study Arms (2)

Laser+Topical corticosteroid

ACTIVE COMPARATOR

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

Laser+Petrolatum gel

PLACEBO COMPARATOR

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

Interventions

0.05% Clobetasol propionate DRUG

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

Laser+Topical corticosteroid

Petrolatum gel DRUG

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

Laser+Petrolatum gel

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

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

Laser+Petrolatum gel; Laser+Topical corticosteroid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Clobetasol; Lasers

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

TH (1)