- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536100
VENEZE Peptide Factor Hair Serum Compared With Topical 2% Minoxidil for Androgenetic Alopecia (VENEZE-AGA)
Effectiveness and Tolerability of VENEZE Peptide Factor Hair Serum for Pattern Hair Loss: A Randomized Double-blind Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chinmanat Lekhavat, MD, PhD
- Phone Number: 1828 66023545222
- Email: chinmanat@inderm.org
Study Contact Backup
- Name: Suchanaree Laitrakul, MD
- Phone Number: 1828 66023545222
Study Locations
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Bangkok, Thailand
- Recruiting
- Institute of dermatology
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Bangkok
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Bangkok, Bangkok, Thailand, 10400
- Recruiting
- Institute of dermatology
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Contact:
- Suchanaree Laitrakul, MD
- Phone Number: 66023545222
- Email: jahjaahh.scnr@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: VENEZE Peptide factor hair serum
Participants in this arm will receive the VENEZE peptide factor hair serum applied topically to the scalp for 24 weeks.
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Participants will apply the VENEZE peptide factor hair serum to the affected scalp areas twice daily for 24 weeks according to the study protocol
Other Names:
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Active Comparator: Topical 2% minoxidil solution
Participants in this arm will receive 2% minoxidil solution applied topically to the scalp for 24 weeks.
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Topical minoxidil solution applied to the scalp according to the study protocol for the treatment of androgenetic alopecia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hair density from baseline
Time Frame: 12 and 24 weeks
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Change from baseline in hair count within approximately 1 cm² target area at the vertex scalp, measured using standardized macrophotographic techniques at Weeks 12 and 24.
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12 and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Investigator Global Aesthetic Improvement Scale
Time Frame: 12 and 24 weeks
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Investigator assessment of treatment response using the Global Aesthetic Improvement Scale at the vertex and frontal scalp regions at baseline, week 12, and week 24.
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12 and 24 weeks
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Change in androgenetic alopecia severity
Time Frame: 12 and 24 weeks
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Change in AGA severity based on Norwood-Hamilton classification in males and Ludwig classification in females at baseline, week 12, and week 24.
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12 and 24 weeks
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Patient Global Assessment of hair growth
Time Frame: 12 and 24 weeks
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Change in patient-reported hair growth and satisfaction assessed using Patient Global Assessment (PGA) and Hair Growth Questionnaire scores at baseline, week 12, and week 24.
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12 and 24 weeks
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Incidence of adverse events
Time Frame: 24 weeks
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Incidence and severity of treatment-related adverse events recorded from baseline until the end of the study.
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24 weeks
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Change in hair diameter and terminal hair count from baseline
Time Frame: 12 and 24 weeks
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Change from baseline in hair diameter and the number of terminal hairs within approximately 1 cm² target area at the vertex scalp, measured using standardized macrophotographic techniques at Weeks 12 and 24.
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12 and 24 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chinmanat Lekhavat, MD, PhD, Institute of dermatology
- Principal Investigator: Suchanaree Laitrakul, MD, Institute of dermatology
Publications and helpful links
General Publications
- 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.
- 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.
- Truong VL, Jeong WS. Hair growth-promoting mechanisms of red ginseng through Wnt/β-catenin. Plants (Basel). 2021;10(10):2067.
- Fang C, Chen Y, Zhao L, Huang Y, Li J, Xu Y, et al. Ginsenoside CK inhibits androgenetic alopecia by regulating dihydrotestosterone and Wnt/β-catenin in mice. Food Front. 2023;4(1):96-108.
- Jeong G, Kim H, Ahn J, Yoon J, Lee J, Cho AR, et al. Ginsenoside Re prevents catagen by activating autophagy and Wnt/β-catenin in human dermal papilla cells. Int J Mol Sci. 2022;23(9):4885.
- Zhang B, Zhang W, Luo J, He J, Zheng X, Zhu S, Rong B, Ai Y, Zhang L, He T. Effects of oleanolic acid on hair growth in mouse dorsal skin mediated via regulation of inflammatory cytokines. J Appl Biomed. 2023 Apr;21(1):48-57. doi: 10.32725/jab.2023.003. Epub 2023 Mar 27.
- Huh S, Lee J, Jung E, Kim SC, Kang JI, Lee J, Kim YW, Sung YK, Kang HK, Park D. A cell-based system for screening hair growth-promoting agents. Arch Dermatol Res. 2009 Jun;301(5):381-5. doi: 10.1007/s00403-009-0931-0. Epub 2009 Mar 11.
- Voiculescu VM, Raducan A, Popa LG, Cretu A, Draghici CC, Voinescu DC, et al. Comparative study of a topical and oral combination (Minoxicapil) in androgenetic alopecia: a 3-month clinical study. Cosmetics (Basel). 2025;12(4):152.
- Thom E, Wadstein J. Treating female diffuse hair loss using Nourkrin® Woman (with Marilex®) - an open-label, subjective, outcome study on hair growth and appearance, self-confidence and treatment satisfaction. J Clin Dermatol Ther. 2019;5:037.
- Couchman JR. Hair follicle proteoglycans. J Invest Dermatol. 1993 Jul;101(1 Suppl):60S-64S. doi: 10.1111/1523-1747.ep12362642.
- Lucky AW, Piacquadio DJ, Ditre CM, Dunlap F, Kantor I, Pandya AG, Savin RC, Tharp MD. A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. J Am Acad Dermatol. 2004 Apr;50(4):541-53. doi: 10.1016/j.jaad.2003.06.014.
- Shin HS, Park SY, Choi JS, Park JS, Lee JH. Promotion of hair growth by ginsenoside-Rb1 through dermal papilla cell proliferation and Wnt/β-catenin signaling. Phytother Res. 2014;28(12):1873-9.
- Harada N, Okajima K, Arai M, Kurihara H, Nakagata N. Administration of capsaicin and isoflavone promotes hair growth by increasing insulin-like growth factor-I production in mice and in humans with alopecia. Growth Horm IGF Res. 2007 Oct;17(5):408-15. doi: 10.1016/j.ghir.2007.04.009. Epub 2007 Jun 13.
- Drake L, Hordinsky M, Fiedler V, Swinehart J, Unger WP, Cotterill PC, Thiboutot DM, Lowe N, Jacobson C, Whiting D, Stieglitz S, Kraus SJ, Griffin EI, Weiss D, Carrington P, Gencheff C, Cole GW, Pariser DM, Epstein ES, Tanaka W, Dallob A, Vandormael K, Geissler L, Waldstreicher J. The effects of finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia. J Am Acad Dermatol. 1999 Oct;41(4):550-4.
- Gupta AK, Talukder M, Williams G. Comparison of oral minoxidil, finasteride, and dutasteride for treating androgenetic alopecia. J Dermatolog Treat. 2022 Nov;33(7):2946-2962. doi: 10.1080/09546634.2022.2109567. Epub 2022 Aug 15.
- Whiting DA. Possible mechanisms of miniaturization during androgenetic alopecia or pattern hair loss. J Am Acad Dermatol. 2001 Sep;45(3 Suppl):S81-6. doi: 10.1067/mjd.2001.117428.
- Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Thom E. Pregnancy and the hair growth cycle: anagen induction against hair growth disruption using Nourkrin(R) with Marilex(R) , a proteoglycan replacement therapy. J Cosmet Dermatol. 2017 Sep;16(3):421-427. doi: 10.1111/jocd.12286. Epub 2016 Sep 23.
- Tr P, Ts R, K SK, Prasanna H. A Comparative Study of Topical Procapil With Platelet-Rich Plasma Therapy Versus Topical Redensyl, Saw Palmetto, and Biotin With Platelet-Rich Plasma Therapy in the Treatment of Androgenetic Alopecia. Cureus. 2023 May 8;15(5):e38696. doi: 10.7759/cureus.38696. eCollection 2023 May.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 031/2568
- IRB-IOD-031/2568 (Other Identifier: Institute of Dermatology, Thailand)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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