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

Phase 2

Completed

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

• Registration Number: TCTR20221111003
• Lead Sponsor: Mae Fah Luang University

Brief Summary

The study showed that pure Saw Palmetto Extract lotion effectively treated male Androgenetic Alopecia. Over 12 weeks, it significantly increased hair count, boosted terminal hair growth, and decreased vellus hair. Participant satisfaction improved notably, with most expressing high satisfaction by study's end. Dermatologists' photographic assessments confirmed increased hair density. The treatment was safe, with only one minor, temporary side effect reported.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-11
• Study Completion: 2023-12-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hair Count Day 0, 4 weeks, 8 weeks and 12 weeks Aramo SG Skin and Hair Diagnostic System

Secondary Outcome Measures

Name	Time	Method
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