Thulium Laser and Growth Factors for Androgenetic Alopecia

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Androgenetic Alopecia (AGA)

Treatments: Procedure: Thulium laser + growth factor serum; Procedure: Thulium laser; Procedure: Thulium laser + growth factor serum + LED

Study type: Interventional

Funder types: Other

Identifiers

NCT07079657

04-23

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Thulium laser + growth factor serum + LED

Active Comparator group

Description:

Thulium laser + growth factor serum + LED

Treatment:

Procedure: Thulium laser + growth factor serum + LED

Thulium laser + growth factor serum

Active Comparator group

Description:

Thulium laser + growth factor serum

Treatment:

Procedure: Thulium laser + growth factor serum

Thulium laser

Active Comparator group

Description:

Thulium laser

Treatment:

Procedure: Thulium laser