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HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00830908
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC

Tracking Information
First Submitted Date  ICMJE January 26, 2009
First Posted Date  ICMJE January 28, 2009
Last Update Posted Date June 27, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2009)
  • Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12 [ Time Frame: 12 weeks ]
  • % of subjects achieving a week 12 PGA grade of '1: slight' or '0: none' [ Time Frame: 12 weeks ]
  • % of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12 [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Official Title  ICMJE An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Seborrheic Dermatitis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: LaserComb
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
Intervention: Device: HairMax LaserComb
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 27, 2009)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00830908
Other Study ID Numbers  ICMJE LEX0903
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexington International, LLC
Study Sponsor  ICMJE Lexington International, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aditya Gupta, M.D., Ph.D. Mediprobe Research Inc.
PRS Account Lexington International, LLC
Verification Date June 2012

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