HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

NCT ID: NCT00830908

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-09-30

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.

Conditions

Seborrheic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LaserComb

Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp

Group Type: EXPERIMENTAL

HairMax LaserComb

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lexington International, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aditya Gupta, M.D., Ph.D.

Role: STUDY_DIRECTOR

Mediprobe Research Inc.

Locations

Mediprobe Research Inc

London, Ontario, Canada

Countries

Canada

Other Identifiers

LEX0903

Identifier Type: -

Identifier Source: org_study_id