Clinical Trial: HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.

Brief Summary: The purpose of this study is to test whether the stimulation of vascularization and cellular metabolism on the scalp by use of the HairMax LaserComb will produce improvement in the condition of scalp seborrheic dermatitis.

Detailed Summary:

This is an open label pilot study to evaluate the effects of the low-level laser light on seborrheic dermatitis of the scalp. Dandruff assessment scores for scalps with seborrheic dermatitis will be assessed at baseline with monthly evaluations during treatment, until final assessment at end of treatment at week 12.

The trial will involve 10 patients aged 18 years and older with a diagnosis of seborrheic dermatitis. Patients will use the LaserComb device three times per week on non-consecutive days for 12 weeks. No other seborrheic dermatitis products will be used during treatment. The investigator will conduct measurements of dandruff at each study visit, as a measure of efficacy.

The trial consists of 4-5 study visits (screening/baseline, week 4, week 8 and week 12). Dandruff evaluation and adverse event assessments will be performed at each visit.

Safety analysis will be assessed based on the reports of adverse events during the study.


Sponsor: Lexington International, LLC

Current Primary Outcome: Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12 [ Time Frame: 12 weeks ]
  • % of subjects achieving a week 12 PGA grade of '1: slight' or '0: none' [ Time Frame: 12 weeks ]
  • % of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12 [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Lexington International, LLC

Dates:
Date Received: January 26, 2009
Date Started: January 2009
Date Completion:
Last Updated: June 25, 2012
Last Verified: June 2012