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 range18 Years – 50 Years
SexALL
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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.
What they're measuring
1
Proportion of subjects achieving a Global Outcome Score (GOS) of 0, 1 or 2 at week 12