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Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment
This study has been completed.
First Received: February 2, 2006   Last Updated: May 21, 2008   History of Changes
Sponsor: Mahidol University
Information provided by: Mahidol University
ClinicalTrials.gov Identifier: NCT00287001
  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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Moles
U.S. FDA Resources

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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
Study First Received: February 2, 2006
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00287001     History of Changes
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Acquired bilateral nevus of Ota-like macules
Postinflammatory hyperpigmentation
Cold air cooling

Additional relevant MeSH terms:
Neoplasms
Hyperpigmentation
Neoplasms by Histologic Type
Skin Diseases
 Pigmentation Disorders
Nevi and Melanomas
Nevus

ClinicalTrials.gov processed this record on November 09, 2009



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