Androgenetic Alopecia (AGA)
Conditions
Keywords
Androgenetic alopecia, Peptide hair serum, Minoxidil
Brief summary
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.
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.
Interventions
OTHERVeneze 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
Topical minoxidil solution applied to the scalp according to the study protocol for the treatment of androgenetic alopecia.
Sponsors
Institute of Dermatology, Thailand
MEDEZE Cosmeceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned in a parallel-group design to receive either the peptide factor hair serum or 2% minoxidil solution for 24 weeks. Participants in each group will receive the assigned intervention throughout the study period. Efficacy outcomes and tolerability will be assessed and compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hair density from baseline | 12 and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hair diameter and terminal hair count from baseline | 12 and 24 weeks | 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. |
| Investigator Global Aesthetic Improvement Scale | 12 and 24 weeks | 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. |
| Change in androgenetic alopecia severity | 12 and 24 weeks | Change in AGA severity based on Norwood-Hamilton classification in males and Ludwig classification in females at baseline, week 12, and week 24. |
| Patient Global Assessment of hair growth | 12 and 24 weeks | 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. |
| Incidence of adverse events | 24 weeks | Incidence and severity of treatment-related adverse events recorded from baseline until the end of the study. |
Countries
Thailand
Contacts
CONTACTChinmanat Lekhavat, MD, PhD
CONTACTSuchanaree Laitrakul, MD
PRINCIPAL_INVESTIGATORChinmanat Lekhavat, MD, PhD
Institute of Dermatology
PRINCIPAL_INVESTIGATORSuchanaree Laitrakul, MD
Institute of Dermatology
Outcome results
None listed