RESUMO
BACKGROUND AND AIM: Male and female pattern baldness, commonly known as androgenetic alopecia is the most common type of alopecia, often predetermined genetically, which generally affects the scalp and is characterized by progressive terminal hair loss, known as miniaturization. This study aimed to assess the safety and efficacy of Kerascalp hair serum, a unique combination of esculin, ximenynic acid, and lauric acid, extracted from natural sources in subjects with mild to moderate androgenetic alopecia. METHODS: An open-label, single-arm clinical study was conducted on healthy males and females aged 18-60 years. Each subject applied the hair serum once daily for 90 days. The efficacy of hair serum was evaluated in terms of the following outcome variables: anagen and telogen ratio (A:T ratio), hair thickness, hair density, hair fall, and hair strength assessment. Subjects were assessed on day 0, day 30, day 60, day 90, and on follow-up day 120. RESULTS: Thirty subjects completed all assessment visits. After using the hair serum for 90 days, statistically significant (p<0.0001) improvement was observed in A:T ratio, hair density, hair thickness, and hair strength; a statistically significant reduction (p<0.0001) in hair fall was also observed. Moreover, improvement in general appearance of hair (in terms of hair volume and density) and scalp (in terms of itchiness, redness, roughness, and dryness) was recorded through dermatological assessment at each treatment visit and at follow-up visit compared to baseline. No adverse event was recorded during the study period, and on follow-up. CONCLUSIONS: The results of this clinical study suggest that a 90 days treatment with a phyto-ingredient-based Kerascalp hair serum is safe and effective in significantly improving A:T ratio, hair density, hair thickness, and hair strength, while reducing hair shedding. The improvement in the test parameters persists, even 30 days after stopping the usage of the serum.
RESUMO
Androgenic alopecia (AA) is a condition that most commonly affects adult men and is caused by an increase in the hormone dihydrotestosterone (DHT) in the hair follicles. Anti-alopecia drugs should be discovered for hair follicles to enter the anagen growth phase. Therefore, this study evaluated the hair growth-promoting activity of Noni fruit's water, ethyl acetate, n-hexane fractions, and sub-fractions from the active fraction in the alopecia male white rabbit model. The Matias method was modified by inducing rabbits using DHT for 17 days, followed by topical application of Noni fruit solution for 21 days. Meanwhile, hair growth was evaluated by histological observation of the follicular density and the anagen/telogen (A/T) ratio in skin tissue. In the first stage, five groups of male white rabbits were studied to obtain the active fraction; DHT+Minoxidil as standard, DHT+vehicle (NaCMC 1%), DHT+FW, DHT+FEA, and DHT+FH. The FEA as the active fraction was followed by open-column chromatography separation (DCM:Methanol) with a gradient of 10% to produce sub-fractions. In the second stage, the six main sub-fraction groups of male rabbits studied were DHT+FEA-1 to DHT+FEA-6. The follicular density of groups FEA-3 was 78.00 ± 1.52 compared with 31.55 ± 1.64 and 80.12 ± 1.02 in the Vehicle and Minoxidil groups. Additionally, group FEA-3 showed large numbers of anagen follicles with an A/T ratio of 1.64/1 compared to the vehicle group of 1/1.50 and 1.39/1 for Minoxidil control. Group FEA-3 was identified by LC-MS/MS-QTOF, followed by molecular docking to the androgen receptor (PDB: 4K7A), causing alopecia. The results showed that three alkaloid compounds with skeleton piperazine and piperidine, namely (compounds 2 (−4.99 Kcal/mol), 3 (−4.60 Kcal/mol), and 4 (−4.57 Kcal/mol)) had a binding affinity similar to Minoxidil, with also has alkaloid skeleton piperidine−pyrimidine (−4.83 Kcal/mol). The dynamic behavior showed the stability of all androgen receptor compounds with good RMSD, SMSF, and SASA values after being studied with 100 ns molecular dynamics (MD) simulations. This study produced a common thread in discovering a class of alkaloid compounds as inhibitors of androgen receptors that cause alopecia.