Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00402129
• Date of registration: 20/11/2006
• Primary sponsor: United States Naval Medical Center, San Diego
• Public title: Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI
• Scientific title: Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control: Task 2.4
• Date of first enrolment: January 2006
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00402129
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: E. Victor Ross, MD
• Affiliation: Scripps Green Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- active duty males/females, 18 years of age or older, Fitzpatrick skin types IV to
VI, and all presented with a pseudofolliculitis barbae as determined by one of the
dermatologists participating in the study

Exclusion Criteria:

- history of vitiligo, photosensitivity, keloids, or herpes simplex in the treatment
area, or any chronic medical conditions that may impair wound healing, such as
diabetes mellitus and collagen vascular disorders



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pseudofolliculitis Barbae

Intervention(s)

Procedure: 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.

Primary Outcome(s)

Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.

Secondary Outcome(s)

In addition, hair and papule counts were performed on a subset of five patients.

Secondary ID(s)

CIP#S-05-121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors