1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMontefiore Medical Center
About this trial
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss
Subject must voluntarily sign and date an IRB approved informed consent form
Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months
Disqualifiers
Subject does not have the capacity to consent to the study
Subject has other types of alopecia of the scalp like alopecia areata
History of intralesional steroid injections to the scalp in the last 12 months
Pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
Sciton HALO 1470nm Non-ablative laser
DevicePatients will be treated with the 1470nm non-ablative laser.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Androgenetic AlopeciaExperimental treatment 1 intervention
Group B: Scarring AlopeciaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Live and Photographic assessment of hair loss
Live and Photographic assessment of hair loss will be assessed using the 7-point Clinician rated Global Aesthetic Improvement Scale (CGAIS). The GAIS is a standardized tool used in dermatology and aesthetic medicine to evaluate treatment success for hair loss (such as androgenetic and scarring alopecia). The 7-point GAIS is scored using a scale ranging from -3 (Greatly decreased - hair growth and density) to 3 (Greatly increased - hair growth and density). A score of zero represents no change.
Time frame
Month 1 (baseline), Month 2, Month 3, Month 6, Month 9, Month 12, Month 152
Hair Density
Hair density will be assessed using the Canfield HairMetrix imaging device. The average number of hairs per follicular unit will be summarized by arm using descriptive statistics.
Time frame
Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)3
Hair Counts
Hair counts will also be assessed using the Canfield HairMetrix imaging device. Hair counts/cm\^2 will be summarized by study arm using descriptive statistics.
Time frame
Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)Secondary outcomes
1
Subject Satisfaction - Overall
Overall subject satisfaction will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics.
Time frame
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 152
Subject Satisfaction - Hair Thickness
Subject satisfaction with hair thickness will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair THICKNESS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics.
Time frame
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 153
Subject Satisfaction - Hair Shedding/Loss
Subject satisfaction with hair shedding/loss will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics.
Time frame
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 154
Subject Satisfaction - Hair Darkness
Subject satisfaction with hair darkness will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair DARKNESS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics.
Time frame
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
Sciton
Collaborator
Source ClinicalTrials.gov