Thulium Laser and Growth Factors for Androgenetic Alopecia - a Prospective, Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Subject Global Aesthetic Improvement Scale
Study Overview
Brief Summary
Androgenetic alopecia (AGA) is a common cause of hair loss worldwide. It mainly affects the frontal and parietal regions of the scalp in up to 70 % of men and 40 % of women and has a significant negative psychological and emotional impact on those affected.
Various therapies are currently approved for the treatment of AGA in men and women, including topical minoxidil, topical or systemic finasteride, platelet-rich plasma and hair transplantation. In addition to these pharmacological and surgical interventions, laser therapies including thulium laser with growth factors have gained popularity.
Despite the clinical use of the thulium laser with growth factors in combination with LED phototherapy, there are only a few studies to date that have adequately investigated the objective and patient-side benefits of this therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged 18 and over
- •Good general health, no relevant previous illnesses
- •Presence of an AGA
- •Cognitive ability and willingness to give consent (informed consent)
- •Be willing and able to attend follow-up visits
Exclusion Criteria
- •Age < 18 years
- •Pregnant or breastfeeding women
- •Scarring alopecia, alopecia due to dermatoses (e.g. lichen ruber, lupus erythemodes,...), alopecia due to chemical or physical noxae, and other non-AGAs
- •Significant scarring of the region to be treated
- •Significant open wounds or lesions in the region to be treated
- •Metallic implants in the head region
- •Mental illnesses (psychoses, body perception disorders)
- •Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
- •Resurfacing (fractional, ablative, non-ablative) of the affected region < 2 months before and during the study period
- •Tendency to excessive scarring
- •Lack of informed consent and/or data protection declarations
Arms & Interventions
Thulium laser
Thulium laser
Intervention: Thulium laser (Procedure)
Thulium laser + growth factor serum + LED
Thulium laser + growth factor serum + LED
Intervention: Thulium laser + growth factor serum + LED (Procedure)
Thulium laser + growth factor serum
Thulium laser + growth factor serum
Intervention: Thulium laser + growth factor serum (Procedure)
Outcomes
Primary Outcomes
Subject Global Aesthetic Improvement Scale
Time Frame: 1 and 6 months post-treatment
scale from 0 (very much improved) to 4 (worse)
Hair density
Time Frame: at baseline, and 1 and 6 months post-treatment
measurement of hair density before and after treatment
hair thickness
Time Frame: at baseline, and 1 and 6 months post-treatment
hair thickness before and after treatment
Secondary Outcomes
- pain intensity(Periprocedural)
Investigators
Lynhda Nguyen
Dr. med.
Universitätsklinikum Hamburg-Eppendorf