Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment

NCT ID: NCT00287001

Last Updated: 2008-05-22

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-04-30

Brief Summary

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\- To investigate the benefit of epidermal cooling on the incidence of post inflammatory hyperpigmentation after laser irradiation

Detailed Description

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* 70% incidence of post inflammatory hyperpigmentation has been reported following a Q-switched nd:YAG laser treatment of acquired bilateral nevus of Ota-like macules.
* We assumed that epidermal cooling may minimize the non-specific injury to the epidermis caused during laser irradiation, leading to the decreased incidence of post inflammatory hyperpigmentation.

Conditions

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Nevus Hyperpigmentation

Keywords

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Acquired bilateral nevus of Ota-like macules Postinflammatory hyperpigmentation Cold air cooling

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

1= cool air cooling

Group Type OTHER

Cold air cooling

Intervention Type DEVICE

Interventions

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Cold air cooling

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with acquired bilateral nevus of Ota-like macules.
* At least 18 years old
* No previous treatment on the condition for a minimum period of 1 month.

Exclusion Criteria

* Subjects diagnosed of scleroderma, connective tissue disorders, hematologic disorders, hepatitis, infection, or uncontrolled DM
* History of keloid and/or hypertrophic scar.
* Currently on anti-coagulant
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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Mahidol University

Principal Investigators

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Woraphong - Manuskiatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Manuskiatti W, Sivayathorn A, Leelaudomlipi P, Fitzpatrick RE. Treatment of acquired bilateral nevus of Ota-like macules (Hori's nevus) using a combination of scanned carbon dioxide laser followed by Q-switched ruby laser. J Am Acad Dermatol. 2003 Apr;48(4):584-91. doi: 10.1067/mjd.2003.193.

Reference Type BACKGROUND
PMID: 12664023 (View on PubMed)

Kunachak S, Leelaudomlipi P, Sirikulchayanonta V. Q-Switched ruby laser therapy of acquired bilateral nevus of Ota-like macules. Dermatol Surg. 1999 Dec;25(12):938-41. doi: 10.1046/j.1524-4725.1999.99176.x.

Reference Type BACKGROUND
PMID: 10594626 (View on PubMed)

Raulin C, Grema H. Single-pass carbon dioxide laser skin resurfacing combined with cold-air cooling: efficacy and patient satisfaction of a prospective side-by-side study. Arch Dermatol. 2004 Nov;140(11):1333-6. doi: 10.1001/archderm.140.11.1333.

Reference Type BACKGROUND
PMID: 15545541 (View on PubMed)

Manuskiatti W, Eimpunth S, Wanitphakdeedecha R. Effect of cold air cooling on the incidence of postinflammatory hyperpigmentation after Q-switched Nd:YAG laser treatment of acquired bilateral nevus of Ota like macules. Arch Dermatol. 2007 Sep;143(9):1139-43. doi: 10.1001/archderm.143.9.1139.

Reference Type DERIVED
PMID: 17875874 (View on PubMed)

Other Identifiers

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185/2005

Identifier Type: -

Identifier Source: org_study_id