Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 5:39 AM
Study NCT ID:
NCT00830908
Status:
COMPLETED
Last Update Posted:
2012-06-27
First Post:
2009-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Sponsor:
Lexington International, LLC
Organization:
Study Overview
Official Title:
An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: