The first clinical trial results looked promising, with claims it could improve hair growth and generate new hair follicles. But, since this initial flurry of information, everything has fallen quiet regarding the hair loss solution known as SM04554.
It now appears that Phase 2 and Phase 3 stages of clinical trials for this topical treatment started enrolling on 1st November 2018 and the final data is expected by the Summer of 2020.
Different strength solutions being tested
According to the trial registration information, the studies will be carried out in Turkey across a number of different locations, for a period of 48 weeks. The volunteers will have clinically-diagnosed Male Pattern Hair Loss assessed to be a 3V or 4 on the Norwood-Hamilton scale.
Researchers will study two different strengths of SM04554 and the trial will feature three separate arms: one group will receive SM04554 0.15% solution once per day, another will receive SM04554 0.25% solution once per day, and a third group will receive a placebo solution. Each individual must apply their solution at approximately the same time every day for the duration of the study.
The trial is double-blind and randomised so none of the participants will know which of the three solutions they are using throughout.
Their progress in the treated areas will be measured at baseline, Weeks 12, 24, 36 and 48; it will be measured in terms of non-vellus and vellus hair counts, hair shaft thickness, hair density, overall hair growth and the participants’ satisfaction with their hair.
Is topical finasteride included?
Among the inclusion criteria Turkish men must meet in order to be eligible to take part in the trial, besides being willing to maintain the same hairstyle and hair colour and wash their hair with gentle non-medicated shampoo, is an interesting requirement. It states that men must be “Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown”.
Furthermore, the first point on the exclusion criteria list states, “Males who are sexually active, and have a partner who is capable of becoming pregnant, if neither has had surgery or become sterilized, and/or who are not willing to use condom or whose partner is not using a highly effective method of birth control that includes double barrier, intrauterine device, or hormonal contraceptive combined with single barrier, or abstinence during the study treatment period until 90 days post last dose of study medication”, cannot take part.
The wording in both cases echoes warnings given to men taking the once-a-day tablet finasteride 1mg – one of the only two clinically-proven Male Pattern Hair Loss Treatments that are both MHRA licensed and FDA approved for this purpose. This is suitable for medically-approved men aged 18 and over and women are advised not to come into contact with broken tablets.
Whilst this is currently only authorised in this oral form, there are a number of clinical trials investigating the drug’s potential when applied topically as a gel or as a liquid. This begs the question as to whether Samumed’s product, which is understood to be based around a ‘novel small molecule compound’, may also contain topical finasteride.
We await more information regarding this potential hair treatment and, as soon as new updates become available we will publish them here on Belgravia’s dedicated hair loss blog.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.