Androgenetic Alopecia (AGA)NCT07079657
Thulium Laser and Growth Factors for Androgenetic Alopecia
A study testing Thulium laser + growth factor serum + LED, Thulium laser + growth factor serum and Thulium laser in people with Androgenetic Alopecia (AGA), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- Thulium laser + growth factor serum + LED, Thulium laser + growth factor serum and Thulium laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Lynhda Nguyen, Dr. med., +49 (0)40 7410 54289, l.nguyen@uke.de
About this study
Official title: Thulium Laser and Growth Factors for Androgenetic Alopecia - a Prospective, Clinical Study
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.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- Thulium laser + growth factor serum + LED, Thulium laser + growth factor serum, Thulium laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium laser + growth factor serum + LEDProcedure or surgery
3 sessions at intervals of 6 weeks
Thulium laser + growth factor serumProcedure or surgery
3 sessions at intervals of 6 weeks
Thulium laserProcedure or surgery
3 sessions at intervals of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thulium laser + growth factor serum + LED | Active comparator | Thulium laser + growth factor serum + LED Receives: Procedure: Thulium laser + growth factor serum + LED |
| Thulium laser + growth factor serum | Active comparator | Thulium laser + growth factor serum Receives: Procedure: Thulium laser + growth factor serum |
| Thulium laser | Active comparator | Thulium laser Receives: Procedure: Thulium laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Global Aesthetic Improvement Scale
scale from 0 (very much improved) to 4 (worse)
Measured: 1 and 6 months post-treatment
Hair density
measurement of hair density before and after treatment
Measured: at baseline, and 1 and 6 months post-treatment
hair thickness
hair thickness before and after treatment
Measured: at baseline, and 1 and 6 months post-treatment
Secondary outcomes (1)
pain intensity
pain intensity during treatment using a numeric rating scale from 0 (no pain) to 10 (unbearable pain)
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Dec 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079657
- Sponsor's protocol ID
- 04-23
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Laser and Growth Factors for Androgenetic Alopecia - a Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT07079657
- Acronym / sponsor ID
- 04-23
- Conditions
- Androgenetic Alopecia (AGA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thulium laser + growth factor serum + LED | Active comparator | Procedure: Thulium laser + growth factor serum + LEDThulium laser + growth factor serum + LED |
| Thulium laser + growth factor serum | Active comparator | Procedure: Thulium laser + growth factor serumThulium laser + growth factor serum |
| Thulium laser | Active comparator | Procedure: Thulium laserThulium laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thulium laser + growth factor serum + LED3 sessions at intervals of 6 weeks | Procedure or surgery | Thulium laser + growth factor serum + LED |
| Thulium laser + growth factor serum3 sessions at intervals of 6 weeks | Procedure or surgery | Thulium laser + growth factor serum |
| Thulium laser3 sessions at intervals of 6 weeks | Procedure or surgery | Thulium laser |
Primary outcome
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
1 secondary outcome
pain intensity
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium laser + growth factor serum + LED, Thulium laser + growth factor serum and Thulium laser in people with Androgenetic Alopecia (AGA), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynhda Nguyen, Dr. med. (+49 (0)40 7410 54289, l.nguyen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Global Aesthetic Improvement Scale (time frame: 1 and 6 months post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.