Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

Not Applicable

Completed

• Conditions: Lentigines; Post Inflammatory Hyperpigmentation
• Interventions: Drug: topical 0.05% Clobetasol propionate ointment

• Registration Number: NCT02492373
• Lead Sponsor: Mahidol University

Brief Summary

To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.

Detailed Description

* The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines with Q-switched Nd:YAG laser was 78.3%.

* It has been found that the incidence of PIH decreased to 40% after applied topical high potency steroid 2 days after the laser treatment.

* By these anti-inflammatory and anti-PIH effects of the high potency steroid, the investigators aimed that the application of steroid 2 days before and 2 days after the laser treatment would be better reduction in the incidence of PIH after Q-switched Nd:YAG laser.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-06-27
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Having multiple lentigines on both sides of the face
• Fitzpatrick skin phototype 3-5

Exclusion Criteria

• Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
• Patients who have photosensitive dermatoses
• Pregnancy and lactation woman
• Patients with wound infections (herpes, other) on the day of treatment
• Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
• Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser+steroid 2 days after laser	topical 0.05% Clobetasol propionate ointment	Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment
laser+steroid 2 days before and after laser	topical 0.05% Clobetasol propionate ointment	Before lentigines' treatment with Qs Nd:YAG 532 nm laser, topical 0.05% Clobetasol propionate ointment was applied 2 days on the lesion. Then applied 2 days after the treatment.

Primary Outcome Measures

Name	Time	Method
The incidence of post inflammatory hyperpigmentation	2 weeks	By investigator's observation.

Secondary Outcome Measures

Name	Time	Method
Side effects of topical steroid	Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment	By investigators' observation of telangiectasia, erythema or atrophy.
The patients satisfaction	Follow-up 4, 8, 12 and 24 weeks after the last treatment	By using Quartile grading scale of improvement; 0 = not improve, 1= 1-25% improvement, 2 = 26-50% improvement, 3 = 51-75% improvement and 4 = 76-100% improvement

Trial Locations

Locations (1)

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