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

Hypertrophic Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487212
• Other study ID #: 614/2556 (EC2)
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2015
• Last updated: June 30, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy

Intervention

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
• 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

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar thickness measured by digital calliper		change from baseline in scar thickness at 6 months	Yes
Secondary	Patient and observer scar assessment scale		Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment	Yes