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Androgenic Alopecia TH07 Clinical Trial

ConditionAndrogenic Alopecia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-49
SponsorTriple Hair Inc

About this trial

The goal of this clinical trial is to learn whether a new topical solution, TH07, can help treat androgenic alopecia in men and to learn more about its safety. Participants will be asked to apply either the TH07 solution, a standard hair growth treatment (Minoxidil 5%), or a placebo every day for 24 weeks. At the end of the study, hair growth will be compared in each group to determine which treatment is most effective at increasing hair count.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males, 18 to 49 years of age on the date of enrollment.

Presenting with androgenic alopecia measured as III vertex to V on Hamilton Norwood Scale.

Body Mass Index (BMI) in the range of 19 to 35 kg/m2.

Not administered any systemic or topical treatment for AGA during the last 90 days.

Disqualifiers

Hair transplant or extension surgery.

Hair weaving.

Laser or light therapy on the scalp in the last 6 months.

Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TH07

    Drug

    TH07 (5%Minoxidil, 0.1%Finasteride, 0.03%Latanoprost); topical solution; twice a day

  • TH07

    Drug

    * TH07 (5%Minoxidil, 0.1%Finasteride, 0.03%Latanoprost); topical solution; once a day * Placebo; topical solution; once a day

  • Minoxidil 5% Topical Solution

    Drug

    Minoxidil 5%; topical solution; twice a day

  • Placebo

    Other intervention

    Placebo; topical solution; twice a day

Treatment groups

420 Participants
are divided into 4 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 1 intervention
Group D: Arm DPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Non-vellus hair count

Number of hair in the matched target area measured by phototrichogram

Time frame
Baseline and week 24

Secondary outcomes

1

Hair diameter and cumulative hair thickness

hair thickness is defined as average hair diameter \* hair count in the matched target area / size of matched target area (mm/cm2)

Time frame
Baseline and week 24
2

Subject-reported improvement

self-assessment questionnaire

Time frame
week 24
3

Non-vellus hair count

in the matched target area by phototrichogram between TH07 twice daily, TH07 once daily, and placebo

Time frame
Baseline and week 24
4

Incidence of treatment related adverse events.

reporting of adverse events and serious adverse events

Time frame
through study completion, average 28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Triple Hair Inc

Lead sponsor

Source ClinicalTrials.gov
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