Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment - Full Text View

Purpose

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

Condition	Intervention
Nevus Hyperpigmentation	Device: Cold air cooling

MedlinePlus related topics:

Moles

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following a Q-Switched Nd:YAG Laser Treatment of Acquired Bilateral Nevus of Ota-Like Macules

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Incidence of post inflammatory hyperpigmentation [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Side effects of cold air cooling and clearing rate of pigmented lesion [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	December 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 1= cool air cooling	Device: Cold air cooling

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287001

Locations


Thailand
	Department of Dermatology, Siriraj Hospital, Mahidol University
	Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Investigators


Principal Investigator:	Woraphong - Manuskiatti, M.D.	Mahidol University

More Information

Publications:

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.

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.

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.

Publications indexed to this study:

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.

Responsible Party:	Mahidol University ( Worapong Manuskiatti )
Study ID Numbers:	185/2005
First Received:	February 2, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00287001
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Acquired bilateral nevus of Ota-like macules

Postinflammatory hyperpigmentation

Cold air cooling

Study placed in the following topic categories:

Hyperpigmentation

Nevus of Ota

Skin Diseases

Nevus, Pigmented

Nevus

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Pigmentation Disorders

Nevi and Melanomas

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00287001