Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

May 31, 2016 updated by: Woraphong Manuskiatti, M.D., Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of topical steroid
Time Frame: Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment
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
Time Frame: 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
Follow-up 4, 8, 12 and 24 weeks after the last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Woraphong Manuskiatti, M.D., Department of Dermatology, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 27, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 033/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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