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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287001
First Posted: February 6, 2006
Last Update Posted: May 22, 2008
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.
Information provided by:
Mahidol University
  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: 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

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

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Worapong Manuskiatti, Mahidol University
ClinicalTrials.gov Identifier: NCT00287001     History of Changes
Other Study ID Numbers: 185/2005
First Submitted: February 2, 2006
First Posted: February 6, 2006
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:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases