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

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertrophic Scars

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

Phase: Phase 4

Status: Completed

Sponsored by: Mahidol University

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.

Clinical Details

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

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

Primary outcome: Scar thickness measured by digital calliper

Secondary outcome: Patient and observer scar assessment scale

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information

Starting date: April 2014
Last updated: June 30, 2015

Page last updated: August 23, 2015

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