HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

Last updated: June 25, 2012
Sponsor: Lexington International, LLC
Overall Status: Completed

Phase

N/A

Condition

Rash

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT00830908
LEX0903
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 useof other medicated scalp products during the trial

Exclusion

Exclusion Criteria:

  • Use of any topical or oral products that would affect assessment of the scalp SDcondition, in the opinion of the primary investigator, within the following periodsprior 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 theassessment of SD = washout to be determined by the investigator, as appropriateto the known medication properties

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

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

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

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

Study Design

Total Participants: 10
Study Start date:
January 01, 2009
Estimated Completion Date:
September 30, 2009

Study 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.

Connect with a study center

  • Mediprobe Research Inc

    London, Ontario N5X 2P1
    Canada

    Site Not Available

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