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Clinical Trials/NCT02492373
NCT02492373
Completed
Not Applicable

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

Mahidol University1 site in 1 country21 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
topical 0.05% Clobetasol propionate ointment
Conditions
Lentigines
Sponsor
Mahidol University
Enrollment
21
Locations
1
Primary Endpoint
The incidence of post inflammatory hyperpigmentation
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Woraphong Manuskiatti, M.D.

Professor

Mahidol University

Eligibility Criteria

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

Arms & Interventions

laser+steroid 2 days before and after laser

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.

Intervention: topical 0.05% Clobetasol propionate ointment

laser+steroid 2 days after laser

Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment

Intervention: topical 0.05% Clobetasol propionate ointment

Outcomes

Primary Outcomes

The incidence of post inflammatory hyperpigmentation

Time Frame: 2 weeks

By investigator's observation.

Secondary Outcomes

  • Side effects of topical steroid(Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment)
  • The patients satisfaction(Follow-up 4, 8, 12 and 24 weeks after the last treatment)

Study Sites (1)

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