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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287001
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : May 22, 2008
Sponsor:
Information provided by:
Mahidol University

Study Description
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Brief Summary:
- To investigate the benefit of epidermal cooling on the incidence of post inflammatory hyperpigmentation after laser irradiation

Condition or disease Intervention/treatment Phase
Nevus Hyperpigmentation Device: Cold air cooling Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
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
Study Start Date : December 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles

Arms and Interventions
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Arm Intervention/treatment
1
1= cool air cooling
 Device: Cold air cooling


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of post inflammatory hyperpigmentation [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Side effects of cold air cooling and clearing rate of pigmented lesion [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287001


Locations
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Thailand
Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Woraphong - Manuskiatti, M.D. Mahidol University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Worapong Manuskiatti, Mahidol University
ClinicalTrials.gov Identifier: NCT00287001    
Other Study ID Numbers: 185/2005
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: February 2007
Keywords provided by Mahidol University:
Acquired bilateral nevus of Ota-like macules
Postinflammatory hyperpigmentation
Cold air cooling
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases