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The efficacy and safety of pure Saw palmetto (Serenoa repens) extract lotion in Androgenetic Alopecia: An Open-labelled Quasi Experimental Clinical Study

The efficacy and safety of pure Saw palmetto (Serenoa repens) extract lotion in Androgenetic Alopecia: An Open-labelled Quasi Experimental Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221111003
Enrollment
20
Registered
2022-11-11
Start date
2023-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Androgenetic Alopecia (Norwood-Hamilton type I,II, III and IIIv) Saw Palmetto, Androgenetic Alopecia, AGA

Interventions

Apply 1 ml twice daily, day and night, all over the scalp with emphasis on bald areas, for 3 months
Experimental Drug
Pure Saw Palmetto Extract Lotion

Sponsors

Mae Fah Luang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Males with Mild to Moderate Androgenetic Alopecia (Norwood-Hamilton type I,II, III and IIIv) 2. Age 30-50 years 3. Participants who are not currently using systemic or topical drugs for hair loss 4. Participants who are willing to use the same shampoo, refrain from change in hair style, and refrain from hair dyeing during the study 5. Participants who are willing to refrain from any therapy affecting hair during the study 6. Participants who are willing to have photographs of the treated area taken. 7. Participants who are willing to follow the treatment schedule and post treatment follow-up 8. Participants who are not willing to participate on other studies during the study period

Exclusion criteria

Exclusion criteria: 1. Females with Androgenetic Alopecia 2. Participation in a study of another device or drug within one month prior to enrollment or during the study. 3. Coexisting systemic diseases e.g., Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), uncontrolled hypertension, symptomatic hypotension, hyperthyroidism, hypothyroidism, or pertinent neurological disorders. 4. Suffering from serious medical conditions that could adversely affect hair loss such as immunosuppression/immune deficiency disorders (including HIV), history of cancer or having/undergoing any form of treatment for active cancer, connective tissue disorder, inflammatory bowel disease 5. Scars or ulcers on the scalp 6. Suffering from any active dermatological condition in the treated area such as scalp atrophy, which in the opinion of the investigator might interfere with clinical evaluation. 7. Having hair weave or tattooing of the alopecia area. 8. Hair loss other than from Androgenetic Alopecia such as alopecia areata, scarring alopecia 9. Hair transplantation within 6 months 10. Use of following systemic or topical medications that could affect hair loss within 6 months within the past 6 months - Prescription or over-the-counter systemic or topical treatment specific for androgenic alopecia (such as minoxidil, finasteride, dutasteride). - 5alpha-reductase inhibitors for prostate conditions (e.g., benign prostate hyperplasia, prostate cancer) and hormone replacement therapy for transgenders - Medications with anti-androgenic properties (cyproterone, spironolactone, ketoconazole, flutamide, progesterone, and bicalutamide) - Medications that can potentially cause hypertrichosis (e.g., cyclosporine, diazoxide, phenothiazines, zidovudine, tamoxifen, carpronium chloride), - Medications that can potentially cause alopecia such as oral glucocorticoids, lithium, phenothiazines, tamoxifen. - Botanicals/neutraceuticals for hair growth - Steroids - systemic steroids for more than 14 days (e.g., corticosteroids, anabolic steroids) or topical steroids in the area of hair loss.

Design outcomes

Primary

MeasureTime frame
Hair Count Day 0, 4 weeks, 8 weeks and 12 weeks Aramo SG Skin and Hair Diagnostic System

Secondary

MeasureTime frame
Hair Growth Day 0, 4 weeks, 8 weeks and 12 weeks 7 point Global Photographic Assessment Score,Hair Growth 4 weeks, 8 weeks and 12 weeks Participants satisfaction score

Countries

Thailand

Contacts

Public ContactPhyo Aung

School of Antiaging and Regenerative Medicine, Mae Fah Luang Univeristy, Thailand

6452001012@lamduan.mfu.ac.th0654063081

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026