1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss
A Prospective, Randomized, Evaluator-blind, Clinical Trial Evaluating the 1550nm Non-ablative Fractional or 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Andrea Pacheco
- Phone Number: 858-657-1004
- Email: apacheco@clderm.com
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- West Dermatology Research Center/Cosmetic Laser Dermatology
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult women aged 35-65 years
- Fitzpatrick skin types I-IV
- Presence of female pattern hair loss of the frontal or vertex of scalp (Sinclair (II-IV)
- Must be willing and can comply with all study protocols, including all treatment schedules, follow up visit, assessments, sign a photography release and ICF, and complete the entire course of the study
- Patients with gray hair roots must be willing to dye their gray hair within two weeks of the first appointment and the last 3-month follow-up visit to ensure consistency in evaluator assessments.
- No use of hair growth treatments or procedures within 6 months prior to enrollment (including hair supplements such as Nutrafol)
- Subjects in good general health based on investigator's judgment and medical history
- Negative urine pregnancy test result at the time of study entry
- Subjects will be of non-childbearing potential defined as:
- Having no uterus
- No menses for at least 12 months.
- Or;
- Subjects of childbearing potential must agree to use an effective method of birth control during the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Acceptable forms of birth control below:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Bilateral tubal ligation
- Hysterectomy
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).
Exclusion Criteria:
- No surgery, pregnancy, breast feeding, change in or addition of hormonal contraception in the last 6 months
- No history of iron deficiency anemia, vitamin D deficiency, or thyroid disease (hypothyroidism or hyperthyroidism or currently on thyroid supplementation)
- Use of scalp light or with laser treatment within the last 6 months.
- Use of topical or systemic drugs affecting hair growth within 6 months prior to enrollment (such as oral spironolactone, finasteride, oral or topical minoxidil, and supplements marketed for hair growth such as Nutrafol)
- Supplementation of oral tumeric/curcumin
- History of hair transplant
- Systemic or scalp disease that may affect hair growth (Lupus, alopecia areata, folliculitis decalvans, psoriasis, scalp infection, seborrheic dermatitis, CCCA, telogen effluvium)
- Pregnancy or planned pregnancy during the study or currently breastfeeding.
- Any uncontrolled systemic disease
- History of autoimmune connective tissue disease or thyroid disease.
- Current use of immunosuppressive medication.
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Active dermatitis, metal or other active implants, active infection in the proposed treatment area.
- Subjects with scarring in the treatment areas (scalp) Subjects with a history of keloids will be excluded.
- History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease, history of Bell's Palsy, epilepsy, smoking, pregnancy, and lactation.
- Inability to following the comply with study protocols and regulations
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: GROUP A 1550nm non-ablative fractional laser
Group A: Study subjects will have a total of 4 treatments spaced 4 weeks apart.
No additional topical treatments applied
|
Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
|
|
Active Comparator: GROUP B 1927 thulium fractional laser
Group B: Study subjects will have a total of 4 treatments spaced 4 weeks apart.
No additional topical treatments applied.
|
Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hair count at a predefined 1cm x 1cm scalp location
Time Frame: Baseline and Day 180
|
Measured by the Canfield Hair Matrix System
|
Baseline and Day 180
|
|
Change in hair density (hairs/cm) at the same predefined scalp area
Time Frame: Baseline and Day 180
|
Measured by the Canfield Hair Matrix System
|
Baseline and Day 180
|
|
Change in terminal hair average diameter (in mm) at the predefined location
Time Frame: Baseline and Day 180
|
Measured by the Canfield Hair Matrix System
|
Baseline and Day 180
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sinclair Scale score
Time Frame: Baseline and Day 180
|
Sinclair photo grading scale II-IV Grades 1 thru 5 (system would not allow to paste/insert the photo scale)
|
Baseline and Day 180
|
|
Change in perceived age based on blinded evaluator assessment of global scalp photographs
Time Frame: Baseline and Day 180
|
Estimated age based on posterior scalp evaluation Visit Perceived Age (years) |
Baseline and Day 180
|
|
Subjective Assessment on Hair outcomes
Time Frame: Day 180
|
Category 1 - No improvement 2 - Slight improvement 3 - Moderate improvement 4 - Noticeable improvement 5 - Significant improvement Hair Density Hair Thickness Hair Growth |
Day 180
|
|
Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator
Time Frame: Day 180
|
Description Grade Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
|
Day 180
|
|
Comfort Level Visual Analog Scale
Time Frame: Baseline, Day 30, Day 60, Day 90
|
0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible
|
Baseline, Day 30, Day 60, Day 90
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Hair-1550-vs-1927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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