Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment
This study has been completed.
Sponsor:
Mahidol University
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00287001
First received: February 2, 2006
Last updated: May 21, 2008
Last verified: February 2007
| Tracking Information | |||||
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| 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 |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 |
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| Detailed Description |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Cold air cooling | ||||
| Study Arm (s) | 1
1= cool air cooling
Intervention: Device: Cold air cooling |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | April 2006 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 Number ICMJE | NCT00287001 | ||||
| Other Study ID Numbers ICMJE | 185/2005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Worapong Manuskiatti, Mahidol University | ||||
| Study Sponsor ICMJE | Mahidol University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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