Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
ConditionScarring Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment.
The main questions it aims to answer are:
1. Does a non-ablative laser work to effectively treat scarring alopecia? 2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia?
Participants with scarring alopecia will:
* Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15) * Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous. * Fill out questionnaires at each visit * Keep a diary of any side effects from laser treatments
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
Disqualifiers
Subject does not have capacity to consent to the study
No ethnic or racial group restrictions
Subject does not have scarring alopecia
History of intralesional steroid injections to the scalp in the last 12 months
Trial design
Design model
Single group
Treatments tested in this trial
1470nm non-ablative fractional laser
DevicePatients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm).
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Scarring alopeciaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinician Global Aesthetic Improvement Scale
A clinician will answer the following question after evaluating baseline photos and current photos (at each specified point in time). Please choose the option that better represents the change in hair growth in the treatment area. The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly worsened 2 = Moderately improved 3 = Greatly improved. Higher scores will be associated with improved hair growth in treatment area as assessed by a clinician. Group scores will be summarized by each specified point in time.
Time frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 152
Subject Global Aesthetic Improvement Scale
Subjects will answer the following questions after evaluating baseline photos and current photos (at each specified point in time). Please choose the option that better represents the change in hair growth in each treatment area from baseline to today. The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved, such that higher scores are associated with the subjects' self-assessment of improved aesthetic for each assessment. Group scores will be summarized by each specified point in time.
Time frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 153
Hair density
Hair density assessed using Canfield HairMetrix imaging device measured as average number of hairs (as reported by the device) per follicular unit for each treatment area (patient-dependent).
Time frame
Baseline/Month 1, 2, 3, 4, 6, 9, 12, 154
Hair counts
Hair counts assessed using Canfield HairMetrix imaging device measured as average hair count per square centimeter (as reported by the device) per treatment area (patient-dependent).
Time frame
Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15Secondary outcomes
1
Subject Satisfaction Questionnaire
Comparing baseline photos and current photos of the scalp, the participant will answer the following questions: 1\. Please choose the option that best represents the change in how your hair looks OVERALL in the area treated? 2. Please choose the option that best represents the change in your hair THICKNESS in the area treated? 3. Please choose the option that best represents the change in your hair SHEDDING/LOSS in the area treated? 4. Please choose the option that best represents the change in your hair DARKNESS in the area treated. The options will be: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved. The average values will be reported for each specified point in time for each of the 4 parameters (overall, thickness, shedding/loss, and darkness). Only the first 4 questions of the subject satisfaction questionnaire (as specified above) are considered relevant to the outcome.
Time frame
Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 152
Change in Dermatology Life Quality Index
The participant will answer a series of 10 questions to measure how much their scarring alopecia has affected their life over the past week. It uses a 10-question self-administered questionnaire where each question is scored from 0 to 3, with a total score ranging from 0 to 30. The change from baseline/Month 1 to the end of the study (Month 15) will be summarized. Positive scores will be indicative of greater impact on the quality of life and negative scores will be indicative of reduced impact on the quality of life.
Time frame
From Baseline/Month 1 to Month 15Other outcomes
1
Hair follicle inflammatory and fibrosis pathway gene expression analysis
Subjects will undergo hair plucking twice-once prior to treatment and once more at the 1-month follow-up of the study. Ten hairs will be plucked from scalp and placed immediately into a buffer solution in a de-identified tube. The procedure will take three minutes and will have no lasting side effects. Ribonucleic acid (RNA) will then be extracted, reverse-transcribed to complementary DNA (cDNA), and sequenced. Bioinformatic analysis will be done using Kallisto and DESeq2 software median-of-ratios method. A single unit of measurement (eg., log₂ fold-change or normalized counts) will be used to report all genes of interest, mainly inflammatory and fibrosis pathways implicated in scarring alopecia (eg. -TGF-β1, NLRP3, IL-1β, IL-18, COL1A1, COL3A1, CTGF, CCL2, CCL21, CXCL6).
Time frame
Hair plucking to obtain hair follicle samples will be performed Month 1 (prior to the start of laser treatments) and Month 4 (1-month post completion of laser treatments)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
Sciton
Collaborator
American Society for Laser Surgery and Medicine
Collaborator
Source ClinicalTrials.gov