NCT00287001

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 22, 2008

Status Verified

February 1, 2007

Enrollment Period

4 months

First QC Date

February 2, 2006

Last Update Submit

May 21, 2008

Conditions

Keywords

Acquired bilateral nevus of Ota-like maculesPostinflammatory hyperpigmentationCold air cooling

Outcome Measures

Primary Outcomes (1)

  • Incidence of post inflammatory hyperpigmentation

    2 weeks

Secondary Outcomes (1)

  • Side effects of cold air cooling and clearing rate of pigmented lesion

    12 weeks

Study Arms (1)

1

OTHER

1= cool air cooling

Device: Cold air cooling

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 12664023BACKGROUND
  • 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.

    PMID: 10594626BACKGROUND
  • 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.

    PMID: 15545541BACKGROUND
  • 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.

MeSH Terms

Conditions

NevusHyperpigmentation

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasmsPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Woraphong - Manuskiatti, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 6, 2006

Study Start

December 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 22, 2008

Record last verified: 2007-02

Locations