HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.|
- Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- % of subjects achieving a week 12 PGA grade of '1: slight' or '0: none' [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- % of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
Device: HairMax LaserComb
LaserComb to be used 3 times weekly on non-consecutive days, according to User Manual instructions. Use is preferably following a shower, prior to using any styling products on the hair or scalp. Hair may be wet or dry during treatment.
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.