Health TrialsbyHealthPanel

Phase 2/3 Efficacy and Safety of PP405 in Adult Males

ConditionAndrogenetic Alopecia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18-55
SponsorPelage Pharmaceuticals, Inc.

About this trial

The study is designed to validate efficacy and long term safety of PP405.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.

Able and willing to provide written informed consent

Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.

Have a modified Norwood-Hamilton score of Type IV or Type V

Disqualifiers

Concomitant diagnosis of non-AGA forms of alopecia.

Use of other hair loss treatments within periods specified in protocol.

Use of excluded medications and procedures as specified in protocol.

Diagnosis of other medical conditions as specified in protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PP405 0.05% Topical Gel

    Drug

    Medicated topical gel containing PP405 0.05%

  • Vehicle Topical Gel

    Drug

    Topical gel

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: PP405 0.05% Topical GelExperimental treatment 1 intervention
Group B: Vehicle Topical GelPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in non-vellus target area hair count

Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex

Time frame
Week 24

Secondary outcomes

1

Change from baseline in the Participant Assessment of Scalp Coverage

Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage

Time frame
Week 24
2

≥20% increase from baseline in non-vellus target area hair count

Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count

Time frame
week 24
3

Change from baseline in non-vellus target area hair count

Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex

Time frame
Week 12
4

Change from baseline in the Participant Assessment of Scalp Coverage

Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage

Time frame
Week 12

Other outcomes

Sponsors and contacts

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

Pelage Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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