Seborrheic DermatitisNCT00830908
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
A study testing HairMax LaserComb in people with Seborrheic Dermatitis, run by Lexington International, LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- HairMax LaserComb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- HairMax LaserComb
- Keywords
- seborrheic dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HairMax LaserCombDevice
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 group | Role | What they receive |
|---|---|---|
| LaserComb | Experimental | Patients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp Receives: Device: HairMax LaserComb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12
Measured: 12 weeks
Secondary outcomes (3)
Reduction of the Total Dandruff Sum Score (TDSS) from baseline to week 12
Measured: 12 weeks
% of subjects achieving a week 12 PGA grade of '1: slight' or '0: none'
Measured: 12 weeks
% of subjects achieving at least a 2-grade reduction in PGA from baseline to week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexington International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aditya Gupta, M.D., Ph.D., Study director, Mediprobe Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830908
- Sponsor's protocol ID
- LEX0903
- Status last verified
- Jun 2012
- First submitted
- 26 Jan 2009
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the HairMax LaserComb(r) in the Treatment of Seborrheic Dermatitis of the Scalp.
- ClinicalTrials.gov ID
- NCT00830908
- Acronym / sponsor ID
- LEX0903
- Conditions
- Seborrheic Dermatitis
- Keywords
- seborrheic dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lexington International, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LaserComb | Experimental | Device: HairMax LaserCombPatients aged 18 years and older with a diagnosis of seborrheic dermatitis of the scalp |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HairMax LaserCombLaserComb 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. | Device | LaserComb |
Primary outcome
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12
Time frame: 12 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditya Gupta, M.D., Ph.D. study director
Mediprobe Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HairMax LaserComb in people with Seborrheic Dermatitis, run by Lexington International, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.