PTT-6™, a novel topical hair serum with stem cell growth factors significantly increases hair growth in patients with hair loss - a 12-week prospective, open-label Case series
Nikolaus Duschek 1, Valentina Prinz 1, Mia Cajkovsky 1
1 Yuvell, Aesthetic Clinic & Clinical Trial Center, Vienna, Austria
PTT-6™, a novel topical hair serum with stem cell growth factors significantly increases hair growth in patients with hair loss - a 12-week prospective, open-label Case series
Corresponding author:
Nikolaus Duschek, MD PhD
Yuvell, Aesthetic Clinic & Clinical Trial Center
22/1 Weihburggasse, 1010 Vienna, Austria
Mail: nikolaus.duschek@yuvell.at
Key words: cosmetics, cosmetic dermatology, hair loss, effluvium, alopecia, skin conditioner, stem cell factors, hair growth
Background
Hair loss is a common problem affecting millions of people worldwide that causes significant psychological distress.1,2 The advent of stem cell-derived topical cosmetics means new treatments have become available. In this case series, a topical hair serum containing PTT-6™ from CellResearch Consumer Health is used. Derived from mesenchymal stem cells of the umbilical cord lining, which is the richest source of stem cells in the body, PTT-6™ signals cells to regenerate, increase cell turnover and stimulate the natural production of collagen, elastin and hyaluronic acid. Furthermore, PTT-6™ causes prolongation of the anagen phase, thus, restoration of a normal hair follicle cycle, stimulation of hair follicle development and suppression of apoptotic cues. A topical product like this might help patients to reduce hair loss and improve hair quality with an easily accessible over-the-counter product, without the need to see a dermatologist or face the cost of hair transplantation.
Material and Methods
Hair serum
PTT-6™ is a topical hair serum, which contains over 3,000 proteins, including growth factors and cytokines derived from ethically harvested red deer umbilical cord lining stem cells. Important growth factors within PTT-6™ are Hepatocyte Growth Factor (HGF), Basic-Fibroblast Growth Factors (b-FGF), Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-β (TGF-β), IGF-1 and Platelet-derived Growth Factor (PDGF) – among many others.
Participants
Study participants (female n=5, male n=5) with mean age of 34.1±14.2 years were recruited and enrolled in one site located in Vienna, Austria (Yuvell®). Patients with manifestation and subjective sensation of hair thinning/hair loss were primarily recruited over social media and study recruitment platforms (Probando®).
An on-site screening was performed to identify eligible subjects according to Ex- and Inclusion criteria, presented in Table 1, the latter including the Hamilton-Norwood Scale and the Ludwig scale for male and female hair loss patients, respectively.3 All subjects consented to the use of their demographic as well as study-outcome data for scientific and marketing purposes.
Treatment protocol
Each of the 10 patients disinfected their scalp with 0.5% Chlorhexidine prior to application. The treatment areas were subjectively chosen according to patient’s area of interest and varied slightly from patient to patient. 2.5ml of PTT-6™ was applied onto the treatment area. Afterwards, the respective zone was treated with micro-needling using a 0.5 mm needle length derma stamp, including 3 passes in alternating directions and an additional 2.5ml PTT-6™ was applied and gently rubbed into the scalp. The investigator advised the patients not to wash their hair following the treatment for at least 24 hours and optimally 48 hours.
This treatment cycle was repeated weekly for 12 weeks in total. The patients continued with this weekly treatment at home, they were given a derma stamp and product for each week and returned to the clinic at weeks 4, 6, 7, 10 and 12 for on-site assessments. The assessments included subject reported outcomes such as psychological questionnaires, as well as objective measurement of hair growth using the HairMetrix® software by Canfield Scientific.
Measurements
Phototrichograms for the assessment of hair changes during the treatment period were documented for all patients by 2 trained evaluators by means of the HairMetrix® D200-evo System, using the HairMetrix® software by Canfield Scientific Inc (4 Wood Hollow Road, Parsippany, NJ 07054, USA). Canfield’s non-invasive hair consultation tool provides results immediately during the consultation without cutting the hair. HairMetrix® ensures objective data, and the photographs can be taken by study personnel, no extra laboratory assessment is needed. (Canfield, 2020)
Standardized questionnaires
For the assessment of the patients’ quality of life and subjective treatment experience standardized questionnaires have been used (lit), presented in Supplement 1 and 2.
Results
10 patients, mean age of 34.1±14.2 y, 50% female, as presented in table 2, applied the PTT-6™ according to a treatment protocol, as described in the method section. After 12 weeks of treatment, a significant amplification of the follicular units per square centimeter (sqcm) (P <.05) with an associated decreased intra-follicular distance (P <.05) was detected, as illustrated in Figure 1a and b. Likewise, the total hair count per sqcm increased (P <.05) and thus, the sum of hair width per sqcm (P <.05), as shown in table 3 and Figure 1c and d. Notably, there was neither change in the number of hairs per FU nor in the average hair width. No adverse effects were reported. Subjectively, the standardized questionnaires demonstrated a significant improvement of hair growth, less need to hide hair and an increased quality of life associated with hair loss, as presented in table 4 and Figure 2a-c. 9 out of 10 patients said they would recommend the product.
Discussion
Hair loss is a common condition affecting many patients causing significant distress. Finasteride might be used in men, yet, side effects include loss of libido, reduced sperm count and motility. Postmenopausal women may also be treated, but long-term side effects cannot be excluded. Topical hair treatment with Minoxidil is efficient, but sometimes leads to irritation, must be applied daily and its action is lost immediately with cease of the treatment. Also, it must be prescribed by a doctor, which is associated with additional efforts and costs. Hair transplantation is an expensive and very burdensome surgical intervention, which many patients cannot afford, nor are willing to undergo. With the advent of topical cosmetics consisting of stem cell factors, new treatments are available. Our results clearly demonstrate a significant improvement of hair growth with this novel hair serum containing PTT-6™, which was further stressed by the fact, that on average, 9 out of 10 patients would recommend the product.
References
1. Aukerman, E.L. & Jafferany, M. The psychological consequences of androgenetic alopecia: A systematic review. J Cosmet Dermatol (2022).
2. Huang, C.H., Fu, Y. & Chi, C.C. Health-Related Quality of Life, Depression, and Self-esteem in Patients With Androgenetic Alopecia: A Systematic Review and Meta-analysis. JAMA Dermatol 157, 963-970 (2021).
3. Gupta, M. & Mysore, V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg 9, 3-12 (2016).