Thulium Laser and Growth Factors for Androgenetic Alopecia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thulium laser + growth factor serum + LED

    Procedure/Surgery

    3 sessions at intervals of 6 weeks

  • Thulium laser + growth factor serum

    Procedure/Surgery

    3 sessions at intervals of 6 weeks

  • Thulium laser

    Procedure/Surgery

    3 sessions at intervals of 6 weeks

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Thulium laser + growth factor serum + LEDActive comparator 1 intervention
Group B: Thulium laser + growth factor serumActive comparator 1 intervention
Group C: Thulium laserActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Subject Global Aesthetic Improvement Scale

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

Time frame
1 and 6 months post-treatment
2

Hair density

measurement of hair density before and after treatment

Time frame
at baseline, and 1 and 6 months post-treatment
3

hair thickness

hair thickness before and after treatment

Time frame
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)

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

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