VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic Alopecia

Официальное название

Effectiveness and Tolerability of VENEZE Peptide Factor Hair Serum for Pattern Hair Loss: A Randomized Double-blind Study

Обзор

This study aims to evaluate the effectiveness and tolerability of a peptide-based hair serum compared with topical minoxidil in patients with androgenetic alopecia. Participants will be randomly assigned, in a double-blind manner, to receive either the peptide hair serum or topical minoxidil. The primary objective is to assess improvement in hair growth over the study period, including changes in hair density and hair thickness. Secondary outcomes will include safety and tolerability assessments. The findings of this study may provide evidence supporting an alternative treatment option for patients with androgenetic alopecia.

Подробное описание

Androgenetic alopecia (AGA) is a common condition affecting both men and women and can significantly impact quality of life. Topical minoxidil is a widely used treatment; however, its effectiveness varies and it may cause local adverse effects in some patients. Peptide hair serums have emerged as a potential alternative, with proposed mechanisms including stimulation of hair follicle activity and promotion of hair growth.

This study aims to evaluate the efficacy and safety of a peptide-based hair serum compared with topical minoxidil in patients with androgenetic alopecia. The primary objective is to assess improvement in hair growth, including changes in hair density and hair thickness. Secondary objectives include evaluation of safety, tolerability, and patient-reported outcomes.

This is a randomized, double-blind, parallel-group study. Eligible participants with androgenetic alopecia will be randomly assigned to receive either the peptide-based hair serum or topical minoxidil. Treatments will be administered according to the study protocol over a defined study period.

Efficacy outcomes will include quantitative assessment of hair density and hair thickness. Safety will be evaluated through monitoring of adverse events and local tolerability.

Вмешательства

• Другое Veneze peptide hair serum
  Participants will apply the VENEZE peptide factor hair serum to the affected scalp areas twice daily for 24 weeks according to the study protocol
• Препарат Topical minoxidil
  Topical minoxidil solution applied to the scalp according to the study protocol for the treatment of androgenetic alopecia.

Первичные конечные точки

• Change in hair density from baseline [Срок оценки: 12 and 24 weeks]

Вторичные конечные точки (5)

• Change in hair diameter and terminal hair count from baseline [Срок оценки: 12 and 24 weeks]
• Investigator Global Aesthetic Improvement Scale [Срок оценки: 12 and 24 weeks]
• Change in androgenetic alopecia severity [Срок оценки: 12 and 24 weeks]
• Patient Global Assessment of hair growth [Срок оценки: 12 and 24 weeks]
• Incidence of adverse events [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Male or female participants aged ≥18 years.
• Diagnosed with androgenetic alopecia (AGA): Norwood-Hamilton classification III-V in males or Ludwig classification I-II in females.
• Able to read and write for completion of study questionnaires (e.g., Patient Global Assessment, Hair Growth Questionnaire).
• Willing to comply with study procedures, including maintaining consistent hair color and hairstyle throughout the study.
• Hair length in the non-balding area (vertex surrounding area) ≥2 cm at each visit.
• Able to attend all scheduled visits during the 24-week study period.

Критерии исключения

• Presence of unstable or uncontrolled systemic diseases that may affect hair growth or loss within 6 months prior to screening (e.g., liver, renal, thyroid, cardiovascular, neurological diseases, diabetes, anemia).
• History of malignancy within the past 5 years, except adequately treated basal cell carcinoma or squamous cell carcinoma.
• Psychiatric disorders or other conditions that may affect participant safety or compliance.
• Pregnant or breastfeeding women.

Hair and scalp-related exclusions:

• Diffuse hair thinning involving the occipital area.
• Scalp conditions or diseases affecting hair growth (e.g., tinea infection, non-AGA hair loss, psoriasis, uncontrolled seborrheic dermatitis).
• History of hair transplantation at any time or hair extensions within 6 months prior to screening.
• Use of cosmetic products for hair loss concealment within 2 weeks prior to screening.
• Use of light/laser therapy on the scalp within 3 months prior to screening.
• Use of supplements related to hair growth (e.g., zinc, biotin) within 3 months prior to screening.
• Use of hair products containing active ingredients (e.g., caffeine, peptides) within 3 months prior to screening.
• Hair procedures such as mesotherapy or stem cell injection within 3 months prior to screening.

Medication-related exclusions:

• Known hypersensitivity to study-related products or ingredients.
• Use of dutasteride within 12 months prior to screening.
• Use of systemic cytotoxic agents.
• Use of systemic glucocorticoids within 3 months prior to screening (except inhaled or topical corticosteroids not applied to the scalp).
• Use within 6 months prior to screening of:

• Minoxidil (topical or oral)
• Finasteride (topical or oral)
• Anti-androgenic drugs (e.g., spironolactone, cyproterone acetate, flutamide, bicalutamide)
• Prostaglandin analogs applied to the scalp
• Estrogen or progesterone topical preparations
• Tamoxifen
• Drugs associated with hypertrichosis (e.g., cyclosporine, phenytoin)
• Drugs associated with hair loss (e.g., valproic acid)
• Participation in another clinical trial within 1 month prior to screening or during this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 2 центра

• Institute of dermatology — Bangkok
• Institute of Dermatology — Bangkok

Публикации

• Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, Price VH, Van Neste D, Roberts JL, Hordinsky M, Shapiro J, Binkowitz B, Gormley GJ. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group. J Am Acad Dermatol. 1998 Oct;39(4 Pt 1):578-89. doi: 10.1016/s0190-9622(98)70007-6. PMID 9777765
• Lee YH, Choi HJ, Kim JY, Kim JE, Lee JH, Cho SH, Yun MY, An S, Song GY, Bae S. Ginsenoside Rg4 Enhances the Inductive Effects of Human Dermal Papilla Spheres on Hair Growth Via the AKT/GSK-3beta/beta-Catenin Signaling Pathway. J Microbiol Biotechnol. 2021 Jul 28;31(7):933-941. doi: 10.4014/jmb.2101.01032. PMID 34099599
• Garza LA, Liu Y, Yang Z, Alagesan B, Lawson JA, Norberg SM, Loy DE, Zhao T, Blatt HB, Stanton DC, Carrasco L, Ahluwalia G, Fischer SM, FitzGerald GA, Cotsarelis G. Prostaglandin D2 inhibits hair growth and is elevated in bald scalp of men with androgenetic alopecia. Sci Transl Med. 2012 Mar 21;4(126):126ra34. doi: 10.1126/scitranslmed.3003122. PMID 22440736
• Wadstein J, Thom E, Gadzhigoroeva A. Integral Roles of Specific Proteoglycans in Hair Growth and Hair Loss: Mechanisms behind the Bioactivity of Proteoglycan Replacement Therapy with Nourkrin(R) with Marilex(R) in Pattern Hair Loss and Telogen Effluvium. Dermatol Res Pract. 2020 May 5;2020:8125081. doi: 10.1155/2020/8125081. eCollection 2020. PMID 32425997
• Devjani S, Ezemma O, Kelley KJ, Stratton E, Senna M. Androgenetic Alopecia: Therapy Update. Drugs. 2023 Jun;83(8):701-715. doi: 10.1007/s40265-023-01880-x. Epub 2023 May 11. PMID 37166619
• Bikash C. Topical Alternatives for Hair Loss: Beyond the Conventional. Int J Trichology. 2025 Jan-Feb;17(1):13-19. doi: 10.4103/ijt.ijt_8_23. Epub 2025 Jun 23. PMID 40654553
• Penha MA, Miot HA, Kasprzak M, Muller Ramos P. Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia: A Randomized Clinical Trial. JAMA Dermatol. 2024 Jun 1;160(6):600-605. doi: 10.1001/jamadermatol.2024.0284. PMID 38598226
• Olsen EA, Whiting D, Bergfeld W, Miller J, Hordinsky M, Wanser R, Zhang P, Kohut B. A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol. 2007 Nov;57(5):767-74. doi: 10.1016/j.jaad.2007.04.012. Epub 2007 Aug 29. PMID 17761356

Идентификаторы

NCT: NCT07536100 · 031/2568 · IRB-IOD-031/2568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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