Male Hair Loss Clinical Trial Results for Finasteride Spray

The clinical trial investigating a spray-on form of finasteride - one of the only two male pattern hair loss treatments currently MHRA-licensed and FDA-approved in a 1mg/day oral form - has published its results.

Known as P-3074, the study commenced in August 2016, with interim results published in April 2019 - almost a year after completion - before the full trial data was made available on 20th June 2019.

P-3074 finasteride spray oral tablet version

Held across five countries by Polichem SA, the small-scale interventional trial featured 632 participants, 458 of whom were randomized. The average age was 31-32 for the men taking part, the vast majority of whom were Caucasian, with up to two Asian and/or Black participants in each group.

Three groups were formed, with one group using P-3074 a finasteride placebo, another using a P-3074 vehicle finasteride placebo and another taking oral finasteride as well as a P-3074 vehicle.

The first group (P-3074 'finasteride' placebo tablet) had 189 members at the start and 128 completed the full trial. Of those who did not complete it, 29 withdrew, 2 did not comply with the proper protocols, 6 experienced adverse events, 1 had a lack of efficacy and 23 were lost to follow-up.

The second group (P-3074 vehicle finasteride placebo) had 184 members to start, with 135 completing the full trial. Of those from this group who dropped out, 4 experienced adverse events, 14 were lost to follow-up, 27 withdrew and 4 left for unspecified reasons.

The third group (oral finasteride P-3074 vehicle) had 85 members, with 60 completing the full trial and 25 dropping out. Ten of these withdrew, six were lost to follow-up, six experienced adverse events, one left for unspecified reasons, one left due to a lack of efficacy and one violated the trial protocol.

The P-3074 contained a hair loss solution of 0.25% finasteride which was administered to a dry scalp via spray, and up to four pumps were used in each application for all groups.

Findings show increased hair count

The findings in those who did complete the trial from each group showed the following mean changes in hair growth compared to baseline, based on target area hair counts in the vertex area of each man's scalp (from hairline to crown - the area affected by androgenetic alopecia :

Group 1 (P-3074 finasteride placebo tablet) = the 105 participants analysed saw a mean (standard deviation) increase in hair count of 20.2 (2.88) hairs at 24 weeks; an increase of 20.4 (2.41) was witnessed at the 12 week point.

Group 2 (P-3074 vehicle finasteride placebo tablet) = the 97 participants analysed saw a mean (standard deviation) increase in hair count of 6.7 (3.01) hairs; an increase of 7.6 (2.46) was witnessed at the 12 week point.

Group 3 (oral finasteride P-3074 vehicle) = the 48 participants analysed saw a mean (standard deviation) increase in hair count of 21.1 (3.90) hairs; an increase of 22.5 (3.31) was witnessed at the 12 week point.

When the participants were asked to complete a self-assessment Hair Growth Questionnaire using a scale of 1-5 to assess their satisfaction at both the 12 week and 24 week stages, the following mean (standard error) ratings were recorded. NB. in the marking scale 1 = very satisfied, 2 = satisfied, 3 = neutral, 4 = dissatisfied and 5 = very dissatisfied.

Group 1 (P-3074 finasteride placebo) = 2.9 (0.08) at Week 12, 2.8 (0.09) at Week 24.

Group 2 (P-3074 vehicle finasteride placebo) = 3.0 (0.09) at Week 12, 3.0 (0.10) at Week 24.

Group 3 (oral finasteride P-3074 vehicle) = 2.8 (0.12) at Week 12, 2.9 (0.13) at Week 24.

The rest of the results are published here on the clinicaltrials.gov website.

Serious adverse events and side effects

Whilst the risk of serious adverse events was no higher than 2.7% in any of the three groups, a number of problems were reported. Not all were as a direct result of the medication they were taking, however.

In Group 1, 4 of the 181 (2.21%) patients experienced serious adverse events during the trial. Of these, one was involved in a road traffic accident, another fractured the base of their skull, one person developed chronic obstructive pulmonary disease, one presented with haematoma and the last had hypertension.

In Group 2, 5 of the 181 (2.76%) patients experienced serious adverse events during the trial. Of these, one fractured their ankle, one had injury/procedural complications or poisoning exposure via their father, one developed tendonitis, one got anogenital warts, and another had nasal septum deviation.

In Group 3, one of the 84 participants (1.19%) experienced serious adverse events during the trial due to their being involved in a road traffic accident.

Of the side effects or other adverse effects experienced, the rates at which these occurred across all groups was 40.88% (Group 1), 40.33% (Group 2) and 47.62% (Group 3).

The most common of these were:

• nasopharyngitis (reported by 28 men from Group 1, 24 from Group 2 and 29 from Group 3)
• headache (reported by 17 from Group 1, 20 from Group 2 and 8 from Group 3); and
• toothache (reported by 3 people from Group 1, 3 from Group 2 and 2 from Group 3).

The drug has now progressed to pivotal Phase III clinical trials in the EU but further, wider-ranging, longer-term clinical trials are needed before it can be shown whether P-3074 could be a safe and effective potential hair loss treatment for Male Pattern Baldness.

It would, however, be up against the popular, already-authorised and available, oral tablet form on its own, and a number of topical finasteride products that are in development and are designed to be used in place of finasteride 1mg tablets - not in addition as is the Polichem product's case.

Anyone worried about Male Pattern Hair Loss now is best advised not to wait to see what the 'next big thing' is in terms of treatment developments, given this is a permanent, progressive condition.

As it gets gradually worse over time, causing increasingly thinning hair and/or a receding hairline, anyone noticing signs of this would do well to contact a hair loss specialist for a consultation as soon as they can. This will provide them with a professional diagnosis and personalised treatment recommendations, should they decide they want help in preventing baldness.

Updates on the Polichem P-3074 trials and product development will be posted here on the Belgravia hair loss blog as they become available.