HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830908
• Other study ID #: LEX0903
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: June 25, 2012
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: Lexington International, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Diagnosis of seborrheic dermatitis of the scalp

• PGA of 2 (mild) or greater at baseline

• TDSS score at baseline of 2 or greater, for both scaling and inflammation

• Must agree to use of non-medicated shampoos during study period; must refrain from use of other medicated scalp products during the trial

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:

• Medicated shampoos within 2 weeks of baseline

• Topical scalp medications within 2 weeks of baseline

• Oral medications affecting the scalp within 4 weeks of baseline

• Other medications determined by the investigator to potentially affect the assessment of SD = washout to be determined by the investigator, as appropriate to the known medication properties

• Any current or past medical condition, including active dermatitis or any other dermatological condition, which might interfere with assessment of dandruff

• Patients using any medications that may increase photosensitivity, and thus pose a risk when undergoing LaserComb therapy

• Patients with known adverse reactions, allergy or hypersensitivity to laser light components/light sensitivity conditions

• Patients who have received any investigational drug within 30 days prior to study entry.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

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.

Locations

Country	Name	City	State
Canada	Mediprobe Research Inc	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lexington International, LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12		12 weeks	No
Secondary	Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12		12 weeks	No
Secondary	% of subjects achieving a week 12 PGA grade of '1: slight' or '0: none'		12 weeks	No
Secondary	% of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12		12 weeks	No