Status:

COMPLETED

HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

Lead Sponsor:

Lexington International, LLC

Conditions:

Seborrheic Dermatitis

Eligibility:

All Genders

18-50 years

Phase:

NA

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 ...

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2009

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00830908

Start Date

January 1 2009

End Date

September 1 2009

Last Update

June 27 2012

Active Locations (1)

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Mediprobe Research Inc

London, Ontario, Canada, N5X 2P1