HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00830908
First received: January 26, 2009
Last updated: June 25, 2012
Last verified: June 2012

January 26, 2009
June 25, 2012
January 2009
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00830908 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Seborrheic Dermatitis
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.
Experimental: LaserComb
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
Intervention: Device: HairMax LaserComb
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00830908
LEX0903
Yes
Lexington International, LLC
Lexington International, LLC
Not Provided
Study Director: Aditya Gupta, M.D., Ph.D. Mediprobe Research Inc.
Lexington International, LLC
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP