Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

NCT ID: NCT02492373

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

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.

Conditions

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Lentigines Post Inflammatory Hyperpigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

topical 0.05% Clobetasol propionate ointment

Intervention Type DRUG

Apply only on the treated area twice a day as mentions

Q switched Nd:YAG laser 532 nm

Intervention Type DEVICE

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

Group Type OTHER

topical 0.05% Clobetasol propionate ointment

Intervention Type DRUG

Apply only on the treated area twice a day as mentions

Q switched Nd:YAG laser 532 nm

Intervention Type DEVICE

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

Interventions

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topical 0.05% Clobetasol propionate ointment

Apply only on the treated area twice a day as mentions

Intervention Type DRUG

Q switched Nd:YAG laser 532 nm

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woraphong Manuskiatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Jun HJ, Cho SH, Lee JD, Kim HS. A split-face, evaluator-blind randomized study on the early effects of Q-switched Nd:YAG laser plus Er:YAG micropeel (combined therapy) versus Q-switched Nd:YAG alone in light solar lentigines in Asians. Lasers Med Sci. 2014 May;29(3):1153-8. doi: 10.1007/s10103-013-1489-9. Epub 2013 Nov 29.

Reference Type RESULT
PMID: 24292155 (View on PubMed)

Ho SG, Yeung CK, Chan NP, Shek SY, Chan HH. A comparison of Q-switched and long-pulsed alexandrite laser for the treatment of freckles and lentigines in oriental patients. Lasers Surg Med. 2011 Feb;43(2):108-13. doi: 10.1002/lsm.21045.

Reference Type RESULT
PMID: 21384391 (View on PubMed)

Takiwaki H, Shirai S, Kohno H, Soh H, Arase S. The degrees of UVB-induced erythema and pigmentation correlate linearly and are reduced in a parallel manner by topical anti-inflammatory agents. J Invest Dermatol. 1994 Nov;103(5):642-6. doi: 10.1111/1523-1747.ep12398276.

Reference Type RESULT
PMID: 7963648 (View on PubMed)

Cheyasak N, Manuskiatti W, Maneeprasopchoke P, Wanitphakdeedecha R. Topical corticosteroids minimise the risk of postinflammatory hyper-pigmentation after ablative fractional CO2 laser resurfacing in Asians. Acta Derm Venereol. 2015 Feb;95(2):201-5. doi: 10.2340/00015555-1899.

Reference Type RESULT
PMID: 24854088 (View on PubMed)

Other Identifiers

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Si 033/2015

Identifier Type: -

Identifier Source: org_study_id

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