NCT07079657

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

July 13, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Subject Global Aesthetic Improvement Scale

    scale from 0 (very much improved) to 4 (worse)

    1 and 6 months post-treatment

  • Hair density

    measurement of hair density before and after treatment

    at baseline, and 1 and 6 months post-treatment

  • hair thickness

    hair thickness before and after treatment

    at baseline, and 1 and 6 months post-treatment

Secondary Outcomes (1)

  • pain intensity

    Periprocedural

Study Arms (3)

Thulium laser + growth factor serum + LED

ACTIVE COMPARATOR

Thulium laser + growth factor serum + LED

Procedure: Thulium laser + growth factor serum + LED

Thulium laser + growth factor serum

ACTIVE COMPARATOR

Thulium laser + growth factor serum

Procedure: Thulium laser + growth factor serum

Thulium laser

ACTIVE COMPARATOR

Thulium laser

Procedure: Thulium laser

Interventions

3 sessions at intervals of 6 weeks

Thulium laser + growth factor serum + LED

3 sessions at intervals of 6 weeks

Thulium laser + growth factor serum
Thulium laserPROCEDURE

3 sessions at intervals of 6 weeks

Thulium laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Lynhda Nguyen, Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 23, 2025

Study Start

December 1, 2023

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations