HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

NCT00830908 | Completed DMC

• 1 other identifier: LEX0903
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Dermatitis

Keywords

seborrheic dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12

  12 weeks

Secondary Outcomes (3)

• Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12

  12 weeks

• % of subjects achieving a week 12 PGA grade of '1: slight' or '0: none'

  12 weeks

• % of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12

  12 weeks

Study Arms (1)

LaserComb

EXPERIMENTAL

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

Device: HairMax LaserComb

Interventions

HairMax LaserComb 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.

LaserComb

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lexington International, LLC: lead

Study Sites (1)

Mediprobe Research Inc

London, Ontario, N5X 2P1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Aditya Gupta, M.D., Ph.D.

  Mediprobe Research Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

CA (1)