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Sponsored by: |
Lexington International, LLC |
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Information provided by: | Lexington International, LLC |
ClinicalTrials.gov Identifier: | NCT00830908 |
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.
Condition | Intervention | Phase |
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Seborrheic Dermatitis |
Device: HairMax LaserComb |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp. |
Estimated Enrollment: | 10 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LaserComb: Experimental
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of any topical or oral products that would affect assessment of the scalp SD condition, in the opinion of the primary investigator, within the following periods prior to baseline:
Responsible Party: | Lexington International, LLC ( David Michaels, Managing Director ) |
Study ID Numbers: | LEX0903 |
Study First Received: | January 26, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830908 History of Changes |
Health Authority: | Canada: Health Canada |
seborrheic dermatitis |
Dermatitis, Seborrheic Skin Diseases Skin Diseases, Eczematous |
Sebaceous Gland Diseases Skin Diseases, Papulosquamous Dermatitis |
Dermatitis, Seborrheic Skin Diseases Skin Diseases, Eczematous |
Sebaceous Gland Diseases Skin Diseases, Papulosquamous Dermatitis |