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NCT Number: NCT02492373

Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

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

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Key information

Conditions

Lentigines Hyperpigmentation Lentigo Melanosis Pigmentation Disorders Post Inflammatory Hyperpigmentation Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical 0.05% Clobetasol propionate ointment

Drug

Apply only on the treated area twice a day as mentions

Q switched Nd:YAG laser 532 nm

Device

Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.

Primary outcomes

  1. The incidence of post inflammatory hyperpigmentation

    Time frame: 2 weeks

    By investigator's observation.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2015
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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