HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
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|ClinicalTrials.gov Identifier: NCT00830908|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 27, 2012
|Condition or disease||Intervention/treatment|
|Seborrheic Dermatitis||Device: HairMax LaserComb|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.|
|Study Start Date :||January 2009|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
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.
- Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 [ Time Frame: 12 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830908
|Mediprobe Research Inc|
|London, Ontario, Canada, N5X 2P1|
|Study Director:||Aditya Gupta, M.D., Ph.D.||Mediprobe Research Inc.|