Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

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

Detailed Description
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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.

Official Title
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Effect of Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation Following Q-switched Nd:YAG 532 nm Laser for Treatment of Facial Lentigines - A Pilot Study

Conditions
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Lentigines, Post Inflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: topical 0.05% Clobetasol propionate ointment
* Device: Q switched Nd:YAG laser 532 nm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser+steroid 2 days before and after laser<br>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. | Drug: topical 0.05% Clobetasol propionate ointment<br>* Apply only on the treated area twice a day as mentions<br>Device: Q switched Nd:YAG laser 532 nm<br>* Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.<br>|
| Other: laser+steroid 2 days after laser<br>Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment | Drug: topical 0.05% Clobetasol propionate ointment<br>* Apply only on the treated area twice a day as mentions<br>Device: Q switched Nd:YAG laser 532 nm<br>* Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of post inflammatory hyperpigmentation | By investigator's observation. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of topical steroid | By investigators' observation of telangiectasia, erythema or atrophy. | Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment | 
| The patients satisfaction | 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 | Follow-up 4, 8, 12 and 24 weeks after the last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post inflammatory hyperpigmentation, topical high potency steroid, Qs NdYAG laser