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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:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00287001
First received: February 2, 2006
Last updated: May 21, 2008
Last verified: February 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Birthmarks 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:

Additional 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
Study First Received: February 2, 2006
Last Updated: May 21, 2008
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:
Nevus
Nevus, Pigmented
Nevus of Ota
Hyperpigmentation
Pigmentation Disorders
 Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013