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Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

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ClinicalTrials.gov Identifier: NCT02492373
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., 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.

Condition or disease Intervention/treatment Phase
Lentigines Post Inflammatory Hyperpigmentation Drug: topical 0.05% Clobetasol propionate ointment Device: Q switched Nd:YAG laser 532 nm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. The incidence of post inflammatory hyperpigmentation [ Time Frame: 2 weeks ]
    By investigator's observation.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492373


Locations
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Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Woraphong Manuskiatti, M.D. Department of Dermatology, Siriraj Hospital
Publications of Results:
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Responsible Party: Woraphong Manuskiatti, M.D., Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02492373    
Other Study ID Numbers: Si 033/2015
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Woraphong Manuskiatti, M.D., Mahidol University:
Post inflammatory hyperpigmentation
topical high potency steroid
Qs NdYAG laser
Additional relevant MeSH terms:
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Lentigo
Hyperpigmentation
Melanosis
Pigmentation Disorders
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs