HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis (NCT00830908) | Clinical Trial Compass
CompletedNot Applicable
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Canada10 participantsStarted 2009-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12