Back to resultsHairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Primary Purpose
Seborrheic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HairMax LaserComb
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring seborrheic dermatitis
Eligibility Criteria
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.
Sites / Locations
- Mediprobe Research Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LaserComb
Arm Description
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
Outcomes
Primary Outcome Measures
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12
Secondary Outcome Measures
Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12
% of subjects achieving a week 12 PGA grade of '1: slight' or '0: none'
% of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12
Full Information
NCT ID
NCT00830908
First Posted
January 26, 2009
Last Updated
June 25, 2012
Sponsor
Lexington International, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00830908
Brief Title
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Official Title
An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexington International, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
seborrheic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LaserComb
Arm Type
Experimental
Arm Description
Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp
Intervention Type
Device
Intervention Name(s)
HairMax LaserComb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12
Time Frame
12 weeks
Title
% of subjects achieving a week 12 PGA grade of '1: slight' or '0: none'
Time Frame
12 weeks
Title
% of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya Gupta, M.D., Ph.D.
Organizational Affiliation
Mediprobe Research Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mediprobe Research Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
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