NCT00287001CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Incidence of post inflammatory hyperpigmentation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Incidence of post inflammatory hyperpigmentation
Time Frame: 2 weeks
Secondary Outcomes
- Side effects of cold air cooling and clearing rate of pigmented lesion(12 weeks)
Investigators
Study Sites (2)
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