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

Tracking Information

First Received Date ^ICMJE

February 2, 2006

Last Updated Date

May 21, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of post inflammatory hyperpigmentation

Change History

Complete list of historical versions of study NCT00287001 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- Side effects of cold air cooling
- Clearing rate of pigmented lesion

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Nevus
Hyperpigmentation

Intervention ^ICMJE

Device: Cold air cooling

Study Arms / Comparison Groups

Other: 1= cool air cooling

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00287001

Responsible Party

Worapong Manuskiatti, Mahidol University

Study ID Numbers ^ICMJE

185/2005

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Woraphong - Manuskiatti, M.D.

Mahidol University

Information Provided By

Mahidol University

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP