HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis - Full Text View

Sponsored by:	Lexington International, LLC
Information provided by:	Lexington International, LLC
ClinicalTrials.gov Identifier:	NCT00830908

Purpose

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
Seborrheic Dermatitis	Device: HairMax LaserComb	Phase II

U.S. FDA Resources

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.

Further study details as provided by Lexington International, LLC:

Primary Outcome Measures:

Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
% of subjects achieving a week 12 PGA grade of '1: slight' or '0: none' [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
% of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
LaserComb: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830908

Locations

Canada, Ontario
Mediprobe Research Inc
London, Ontario, Canada, N5X 2P1

Sponsors and Collaborators

Lexington International, LLC

Investigators

Study Director:

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

Mediprobe Research Inc.

More Information

No publications provided

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
Health Authority:	Canada: Health Canada

Keywords provided by Lexington International, LLC:

seborrheic dermatitis

Study placed in the following topic categories:

Dermatitis, Seborrheic
Skin Diseases
Skin Diseases, Eczematous

Sebaceous Gland Diseases
Skin Diseases, Papulosquamous
Dermatitis

ClinicalTrials.gov processed this record on February 12, 2009