Clinical trial NCT00287001: Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nevus
Hyperpigmentation
Keywords: Acquired bilateral nevus of Ota-like macules
Postinflammatory hyperpigmentation
Cold air cooling
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Incidence of post inflammatory hyperpigmentation
timeFrame: 2 weeks
Secondary outcomes:
measure: Side effects of cold air cooling and clearing rate of pigmented lesion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Woraphong - Manuskiatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manuskiatti W, Sivayathorn A, Leelaudomlipi P, Fitzpatrick RE. Treatment of acquired bilateral nevus of Ota-like macules (Hori's nevus) using a combination of scanned carbon dioxide laser followed by Q-switched ruby laser. J Am Acad Dermatol. 2003 Apr;48(4):584-91. doi: 10.1067/mjd.2003.193.
citation: Kunachak S, Leelaudomlipi P, Sirikulchayanonta V. Q-Switched ruby laser therapy of acquired bilateral nevus of Ota-like macules. Dermatol Surg. 1999 Dec;25(12):938-41. doi: 10.1046/j.1524-4725.1999.99176.x.
citation: Raulin C, Grema H. Single-pass carbon dioxide laser skin resurfacing combined with cold-air cooling: efficacy and patient satisfaction of a prospective side-by-side study. Arch Dermatol. 2004 Nov;140(11):1333-6. doi: 10.1001/archderm.140.11.1333.
citation: Manuskiatti W, Eimpunth S, Wanitphakdeedecha R. Effect of cold air cooling on the incidence of postinflammatory hyperpigmentation after Q-switched Nd:YAG laser treatment of acquired bilateral nevus of Ota like macules. Arch Dermatol. 2007 Sep;143(9):1139-43. doi: 10.1001/archderm.143.9.1139.