The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: 90-Day Results.

Glynis Ablon

RCT Journal of cosmetic dermatology 2025 1 citações

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Study Design

Tipo de Estudo: randomized controlled trial
Tamanho da Amostra: 60
Duração: 12.9 weeks

Intervenção: The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: Proprietary saw palmetto (Serenoa repens) bioactive fatty acids extract, 1 oral dose daily for 90 da
Comparador: Placebo
Direção do Efeito: Positive
Risco de Viés: Low

Abstract

BACKGROUND: Hair loss is a global concern for both men and women. AIMS: This study assessed the efficacy and safety of a proprietary extract of bioactive fatty acids from saw palmetto for treating self-perceived thinning hair in healthy adult male and female subjects. METHODS: In this 6-month, randomized, double-blind, placebo-controlled study, subjects were randomized to receive active treatment (n = 40) or placebo (n = 20). Half of the enrolled subjects were female. Subjects took one oral dose of their assigned treatment daily. Assessments were performed at baseline, Day 56 and Day 90. Preliminary 90-day results are presented here. PATIENTS/METHODS: The active group showed significant improvement in terminal hair count from baseline in anterior (p < 0.0007) and posterior (p < 0.0005) areas. Compared to placebo, the improvement was also significant in the anterior (p < 0.05) and posterior (p < 0.03) areas. Anterior vellus hair count improved significantly versus baseline (p < 0.0005) and placebo (p < 0.01). Posterior vellus hair count showed significant within-group growth (p < 0.05). Total hair count was significantly greater than baseline for anterior (p < 0.001) and posterior (p < 0.0005) and significantly greater for anterior (p < 0.005) and posterior (p < 0.05) compared to placebo. Total terminal hair counts improved 7-fold, and total hair count improved 12-fold compared to placebo. A significant reduction in hair shedding was observed in the active group versus baseline (p < 0.05). No meaningful improvements were observed in the placebo group, and no adverse events were reported. CONCLUSION: These preliminary results indicate the daily administration of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT06920758.

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FIGURE 1

Study design or participant flow for the clinical trial assessing a proprietary saw palmetto bioactive fatty acids extract for promoting hair growth in adults with self-perceived thinning hair.

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FIGURE 2

Hair growth outcome measures showing improvements in hair density or shedding rates in participants receiving the saw palmetto extract compared with baseline or control.

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Tables

TABLE 1

	Active	Placebo
	n = 40	n = 20
Mean age, years (SD)	50.6 (9.6)	48.9 (10.9)
Median age, years (min, max)	55.0 (28, 63)	50.5 (29, 63)
Race, n (%)	n = 40	n = 20
White	36 (90)	14 (70)
Black	1 (2.5)	1 (5)
Asian	1 (2.5)	2 (10)
American Indian/Alaskan Native	—	2 (10)
Native Hawaiian/Pacific Islander	—	1 (5)
Mixed race	2 (5)	—
Ethnicity, n (%)	n = 40	n = 20
Hispanic/Latino	32 (80)	15 (75)
Non‐Hispanic/Latins	8 (20)	5 (25)
Fitzpatrick skin type	n = 40	n = 20
Type I	6 (15)	5 (25)
Type II	14 (35)	4 (20)
Type III	12 (30)	5 (25)
Type IV	6 (15)	5 (25)
Type V	2 (5)	—
Type VI	—	1 (5)
Norwood classification scale (male subjects), n (%)	n = 20	n = 10
II	1 (5)	1 (10)
III	8 (40)	7 (70)
III Vertex	11 (55)	2 (20)
Savin pictorial scale (female subjects), n (%)	n = 20	n = 10
1–2	15 (75)	7 (70)
1–3	5 (25)	3 (30)

TABLE 2

	Active (n = 40)			Placebo (n = 20)
	Day 0	Day 90	Change	Day 0	Day 90	Change
Anterior terminal hair counts
Mean (SD)	132.9 (29.2)	144.2 (32.4)	+11.3 (19.4)^a,b	131.8 (30.7)	134.4 (28.9)	+2.7 (14.2)
Median (min, max)	134.5 (60, 202)	145.0 (70, 206)	10.5 (70, 206)	137.5 (85, 199)	135.5 (85, 210)	2.0 (−28, 34)
^a p = 0.00068 versus baseline, 2‐tailed Student's t‐tests for correlated samples. ^b p < 0.05.
Posterior terminal hair counts
Mean (SD)	167.1 (32.9)	179.2 (34.0)	+12.1 (18.7)^a,b	175.2 (34.6)	175.6 (31.7)	+0.6 (18.6)
Median (min, max)	168 (100, 233)	183 (105, 258)	12 (−20, 41)	175 (123, 246)	172 (117, 232)	3 (−39, 31)
^a p < 0.0005 versus baseline, 2‐tailed Student's t‐test for correlated samples. ^b p < 0.05 versus placebo, 2‐tailed Student's t‐test for independent samples.
Anterior vellus hair counts
Mean (SD)	10.8 (9.5)	15.2 (12.6)	+4.4 (9.2)^a,b	14.9 (10.9)	12.2 (11.4)	−2.7 (10.7)
Median (min, max)	8 (0, 37)	11 (0, 50)	3.5 (−11, 28)	14 (0, 35)	8.5 (0, 41)	−1.5 (−32, 11)
^a p < 0.0005 versus baseline, 2‐tailed Student's t‐test for correlated samples. ^b p < 0.01 versus placebo, 2‐tailed Student's t‐test for independent samples.
Posterior vellus hair counts
Mean (SD)	4.8 (6.6)	5.8 (6.9)	+1.0 (8.0)	3.5 (3.1)	5.4 (4.7)	+1.9 (4.2)
Median (min, max)	1 (0, 29)	3 (0, 31)	0 (−22, 20)	3 (0, 11)	4.5 (0, 14)	0 (−6, 10)
Anterior total hair counts
Mean (SD)	143.7 (28.0)	159.4 (30.7)	+15.7 (18.5)^a,b	146.7 (33.3)	146.6 (27.4)	−0.1 (19.8)
Median (min, max)	146.5 (66, 206)	155.5 (97, 219)	13.5 (−31, 52)	142 (98, 222)	139.5 (101, 213)	−1 (−36, 39)
^a p = NS versus baseline, 2‐tailed Student's t‐test for correlated samples. ^b p < 0.005 versus placebo, 2‐tailed Student's t‐test for independent samples.
Posterior total hair counts
Mean (SD)	171.9 (35.4)	185.0 (36.0)	+13.10 (21.4)^a,b	178.7 (33.3)	181.0 (30.2)	+2.3 (18.5)
Median (min, max)	171 (100, 246)	190 (105, 272)	11 (−42, 58)	178 (130, 249)	174.5 (127, 232)	3 (−31, 39)
^a p = 0.0004 versus baseline, 2‐tailed Student's t‐test for correlated samples. ^b p < 0.05 versus placebo, 2‐tailed Student's t‐test for independent samples.

TABLE 3

	Day 0	Day 90	Change	Day 0	Day 90	Change
	Anterior terminal hair counts			Posterior terminal hair counts
Mean (SD)	128.6 (23.76)	138.6 (29.45)	+10 (15.27)^a	185.87 (23.98)	191.8 (27.49)	+5.93 (19.45)
Median (min, max)	128 (82, 169)	142 (90, 206)	8 (−15, 37)	194 (142, 220)	193 (146, 258)	6 (−20, 39)
^a p < 0.05 versus baseline, 2‐tailed Student's t‐tests for correlated samples.
	Anterior vellus hair counts			Posterior vellus hair counts
Mean (SD)	13.6 (9.88)	19.47 (15.59)	+5.87 (11.46)	5.47 (8.88)	6.00 (5.98)	+0.53 (9.28)
Median (min, max)	12 (0, 37)	20 (0, 50)	6 (−11, 28)	0 (0, 29)	6 (0, 15)	0 (−22, 15)
	Anterior total hair counts			Posterior total hair counts
Mean (SD)	142.2 (23.15)	158.07 (28.15)	+15.87 (16.77)^a	191.33 (28.95)	197.8 (29.5)	+6.47 (22.47)
Median (min, max)	145 (96, 178)	155 (110, 206)	13 (−11, 52)	194 (142, 238)	196 (146, 272)	10 (−42, 39)
^a p < 0.005 versus baseline, 2‐tailed Student's t‐test for correlated samples.

TABLE 4

	Active (n = 40)			Placebo (n = 20)
	Day 0	Day 90	Change	Day 0	Day 90	Change
Total number of hairs (summed across all regions), n (%)
Mean (SD)	1.2 (1.0)	0.8 (0.9)	−0.4 (1.1)^a	1.1 (1.3) 1.0 (0.9)	1.0 (0.9)	−0.2 (1.3)
Median (min, max)	1 (0, 3)	1 (0, 3)	0 (−3, 2)	1 (0, 4)	1 (0, 4)	0 (−3, 4)
^a p < 0.05 versus baseline, 2‐tailed Student's t‐test for correlated samples
Number of hairs: vertex, n (%)
Mean (SD)	0.5 (0.6)	0.3 (0.6)	−0.2 (0.7)	0.8 (0.8)	0.4 (0.6)	−0.4 (0.9)
Median (min, max)	0 (0, 2)	0 (0, 2)	0 (−2, 1)	1 (0, 3)	0 (0, 2)	0 (−2, 2)
Number of hair: left parietal, n (%)
Mean (SD)	0.2 (0.5)	0.1 (0.2)	−0.1 (0.5)	0.1 (0.3)	0.1 (0.2)	−0.1 (0.2)
Median (min, max)	0 (0, 2)	0 (0, 1)	0 (−1, 1)	0 (0, 1)	0 (0, 1)	0 (−1, 0)
Number of hairs: right parietal, n (%)
Mean (SD)	0.2 (0.4)	0.1 (0.3)	−0.1 (0.6)	0.2 (0.4)	0.3 (0.4)	0.1 (0.6)
Median (min, max)	0 (0, 1)	0 (0, 1)	0 (−1, 1)	0 (0, 1)	0 (0, 1)	0 (−1, 0)
Number of hairs: occipital, n (%)
Mean (SD)	0.4 (0.7)	0.3 (0.5)	−0.1 (0.7)	0.3 (0.7)	0.3 (0.4)	−0.1 (0.9)
Median (min, max)	0 (0, 3)	0 (0, 2)	0 (−2, 1)	0 (0, 3)	0 (0, 1)	0 (−3, 1)

TABLE 5

Rating n (%)	Active (n = 40)	Placebo (n = 20)
Hair quality
Greatly improved	1 (2.5)	—
Moderately improved	10 (25)	4 (20)
Slightly improved	21 (52.5)	6 (30)
No change	3 (7.5)	7 (35)
Slightly worsened	5 (12.5)	3 (15)
Moderately worsened	—	—
Greatly worsened	—	—
Hair growth
Greatly increased	—	—
Moderately increased	9 (23)	2 (10)
Slightly increased	15 (38)	4 (20)
No change	9 (23)	9 (45)
Slightly decreased	7 (18)	5 (25)
Moderately decreased	—	—
Greatly decreased	—	—

References

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Used In Evidence Reviews

B Saw Palmetto para Perda Capilar de Padrão Feminino

The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: 90-Day Results.

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Abstract

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Used In Evidence Reviews

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