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

Hyperpigmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287001
• Other study ID #: 185/2005
• Status: Completed
• Phase: N/A
• First received: February 2, 2006
• Last updated: May 21, 2008
• Start date: December 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2007
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Hyperpigmentation
• Nevus

Intervention

Device:
• Cold air cooling

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post inflammatory hyperpigmentation		2 weeks	Yes
Secondary	Side effects of cold air cooling and clearing rate of pigmented lesion		12 weeks	Yes