The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair: 180-Day Results.
Glynis Ablon
RCT
Journal of cosmetic dermatology
2026
PubMed
DOI
CC-BY
PDF
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Study Design
- Loại nghiên cứu
- randomized controlled trial
- Cỡ mẫu
- 60
- Thời gian
- 26 weeks
- Can thiệp
- The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair: 180-Day Results. proprietary saw palmetto (Serenoa repens) bioactive fatty acid extract (SEREVELLE) daily; dose not s
- Đối chứng
- Placebo
- Xu hướng hiệu quả
- Positive
- Nguy cơ sai lệch
- Low
Abstract
BACKGROUND: Hair loss remains 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 (Serenoa repens) for treating self-perceived thinning hair in healthy adult men and women (SEREVELLE, Valensa International; Eustis, FL). METHODS: This 6-month, randomized, double-blind, placebo-controlled study assessed the beneficial effects of daily active treatment (n = 40) vs. placebo (n = 20) on several hair growth parameters. RESULTS: Active treatment of SEREVELLE significantly outperformed placebo on all primary endpoints at Day 180. Mean (SD) change in baseline total terminal hair count was +18.6 (29.6) with active vs. -10.1 (30.5) with placebo (p < 0.001; 283% greater improvement). Total vellus hair count increased +6.6 (15.6) vs. -2.1 (15.7) (p < 0.05; 414% greater improvement). Total hair density rose +25.1 (27.7) vs. -12.2 (38.8) (p < 0.001; 306% greater improvement). Subgroup analyses at Day 180 corroborated these advantages: across populations, between-group differences in mean change favored active for subgroup of men, with total terminal hair count (p = 0.003), total vellus hair count (p < 0.001), and total hair density (p < 0.001). In menopausal women, active produced significant placebo-adjusted gains in total terminal hair count (p < 0.05) and total hair density (p < 0.01), with a nonsignificant numerical advantage for total vellus hair count. There were no treatment-related adverse events. CONCLUSION: The daily use of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair.
Full Text
Figures
FIGURE 1
Study design and participant flow for the 180-day trial evaluating a novel saw palmetto (Serenoa repens) extract for hair growth promotion in adults with self-perceived thinning hair.
flowchart
FIGURE 2
Hair growth efficacy outcomes at 180 days comparing the proprietary saw palmetto extract with baseline measurements, indicating improvements in hair density or reduced shedding.
chartTables
TABLE 1
| Active, | Placebo, | ALL, | |
|---|---|---|---|
| Mean age, years (SD) | 50.6 (9.6) | 48.9 (10.9) | 50.0 (10.0) |
| Median age, years (min, max) | 55.0 (28, 63) | 50.5 (29, 63) | 52 (28, 63) |
| Race, |
|
|
|
| White | 36 (90) | 14 (70) | 50 (83) |
| Asian | 1 (2.5) | 2 (10) | 3 (5) |
| Black | 1 (2.5) | 1 (5) | 2 (3) |
| American indian/alaskan native | 2 (10) | 2 (3) | |
| Native hawaiian/pacific islander | 1 (5) | 1 (2) | |
| White/african american | 1 (2.5) | 1 (2) | |
| White/african american/native american | 1 (2.5) | 1 (2) | |
| Ethnicity, |
|
|
|
| Hispanic/Latino | 32 (80) | 15 (75) | 13 (22) |
| Non‐hispanic/Latino | 8 (20) | 5 (25) | 47 (7%) |
| Fitzpatrick skin type, |
|
|
|
| Type I | 6 (15) | 5 (25) | 11 (18) |
| Type II | 14 (35) | 4 (20) | 18 (30) |
| Type III | 12 (30) | 5 (25) | 17 (28) |
| Type IV | 6 (15) | 5 (25) | 11 (18) |
| Type V | 2 (5) | 2 (4) | |
| Type VI | 1 (5) | 1 (2) | |
| Norwood classification scale (male subjects), |
|
|
|
| II | 1 (5) | 1 (10) | 2 (7) |
| III | 8 (40) | 7 (70) | 15 (50) |
| III Vertex | 11 (55) | 2 (20) | 13 (43) |
| Savin pictoral scale (female subjects), |
|
|
|
| 1–2 | 15 (75) | 7 (70) | 22 (73) |
| 1–3 | 5 (25) | 3 (30) | 8 (27) |
TABLE 2
| Active treatment, | Placebo, | |||
|---|---|---|---|---|
| Day 0 | Day 180 | Day 0 | Day 180 | |
|
| ||||
| Mean (SD) | 132.9 (29.2) | 138.5 (30.1) | 131.8 (30.7) | 129.3 (29.1) |
| Median (min, max) | 134.5 (60, 202) | 136 (84, 214) | 137.5 (85, 199) | 136 (74, 168) |
| Change (SD) | 5.5 (23.8) | −2.5 (22.8) | ||
|
| ||||
| Mean (SD) | 167.1 (32.9) | 180.1 (40.2) | 175.2 (34.5) | 167.6 (31.5) |
| Median (min, max) | 168 (100, 233) | 180 (80, 260) | 175 (123, 246) | 165.5 (118, 220) |
| Change (SD) | 13.0 (22.4) | −7.6 (18.4) | ||
|
| ||||
| Mean (SD) | 300.0 (46.1) | 318.6 (48.5) | 306.9 (59.6) | 296.8 (55.8) |
| Median (min, max) | 302.5 (185, 426) | 305.0 (244, 459) | 307.5 (212, 420) | 300.0 (193, 388) |
| Change (SD) | 18.6 (29.6) | –10.1 (30.5) | ||
|
| ||||
| Mean (SD) | 10.8 (9.5) | 14.4 (12.1) | 14.9 (10.9) | 11.1 (9.4) |
| Median (min, max) | 8 (0, 37) | 10 (0, 51) | 14 (0, 35) | 9 (0, 43) |
| Change (SD) | 3.6 (11.3) | −3.9 (13.1) | ||
|
| ||||
| Mean (SD) | 4.8 (6.6) | 7.8 (7.3) | 3.5 (3.1) | 5.3 (5.8) |
| Median (min, max) | 1 (0, 29) | 6 (0, 26) | 3 (0, 11) | 3 (0, 17) |
| Change (SD) | 3.0 (7.7) | 1.7 (6.8) | ||
|
| ||||
| Mean (SD) | 15.5 (13.8) | 22.1 (15.0) | 18.4 (11.7) | 16.3 (13.1) |
| Median (min, max) | 11.5 (0, 55) | 20.0 (0, 57) | 18.0 (0, 41) | 14.5 (0, 57) |
| Change (SD) | 6.6 (15.6) | –2.1 (15.7) | ||
|
| ||||
| Mean (SD) | 143.7 (28.0) | 152.9 (32.6) | 146.7 (33.3) | 140.3 (27.7) |
| Median (min, max) | 146.5 (66, 206) | 154 (87, 220) | 142 (98, 222) | 149.5 (83, 174) |
| Change (SD) | 9.2 (21.6) | −6.3 (28.4) | ||
|
| ||||
| Mean (SD) | 171.9 (35.4) | 187.9 (39.0) | 178.7 (33.3) | 172.8 (32.3) |
| Median (min, max) | 171 (100, 246) | 194 (106, 269) | 178 (130, 249) | 174 (125, 227) |
| Change (SD) | 16.0 (21.9) | −5.8 (20.5) | ||
|
| ||||
| Mean (SD) | 315.6 (48.9) | 340.7 (51.0) | 325.3 (60.5) | 313.1 (5.7) |
| Median (min, max) | 318.0 (191, 452) | 344.0 (255, 471) | 317.50 (239, 436) | 313.5 (208, 394) |
| Change (SD) | 25.1 (27.7) | −12.2 (38.8) | ||
TABLE 3
| Active treatment, | Placebo, | |||
|---|---|---|---|---|
| Day 0 | Day 180 | Day 0 | Day 180 | |
|
| ||||
| Mean (SD) | 144.4 (25.7) | 150.5 (30.2) | 139.3 (35.0) | 131.4 (32.6) |
| Median (min, max) | 147.0 (91, 202) | 142.0 (107, 214) | 137.5 (97, 199) | 138 (74, 168) |
|
| ||||
| Mean (SD) | 151.8 (33.17) | 159.3 (37.8) | 181.9 (38.7) | 164.8 (38.0) |
| Median (min, max) | 148.5 (100, 233) | 155.5 (80, 245) | 184.5 (123, 246) | 165.5 (118, 220) |
|
| ||||
| Mean (SD) | 296.2 (48.4) | 309.9 (52.5) | 321.2 (66.7) | 296.2 (65.1) |
| Median (min, max) | 292.0 (222, 426) | 289.5 (250, 459) | 324.5 (222, 420) | 292.5 (193, 388) |
|
| ||||
| Mean (SD) | 7.1 (7.7) | 15.1 (12.4) | 11.2 (11.4) | 7.1 (5.8) |
| Median (min, max) | 5.0 (0, 30) | 11.0 (0, 51) | 6.0 (0, 31) | 6.0 (0, 17) |
|
| ||||
| Mean (SD) | 4.2 (5.0) | 10.4 (7.8) | 4.7 (3.0) | 3.7 (4.1) |
| Median (min, max) | 2.5 (0, 14) | 9.0 (0, 26) | 4.0 (0, 11) | 3.0 (0, 14) |
|
| ||||
| Mean (SD) | 11.3 (11.2) | 25.5 (15.4) | 15.9 (12.9) | 10.8 (8.0) |
| Median (min, max) | 9.5 (0, 44) | 21.5 (0, 57) | 11.5 (0, 38) | 10.5 (0, 22) |
|
| ||||
| Mean (SD) | 151.5 (24.4) | 165.7 (30.3) | 150.5 (40.6) | 138.5 (31.2) |
| Median (min, max) | 149.5 (115, 206) | 160.0 (122, 220) | 150.5 (105, 222) | 138.5 (83, 174) |
|
| ||||
| Mean (SD) | 156.0 (34.3) | 169.7 (37.5) | 186.6 (37.4) | 168.5 (36.5) |
| Median (min, max) | 157.5 (100, 246) | 168.5 (106, 251) | 188.5 (134, 249) | 167.0 (125, 223) |
|
| ||||
| Mean (SD) | 307.6 (50.5) | 335.4 (56.0) | 337.1 (69.8) | 307.0 (63.1) |
| Median (min, max) | 308.0 (233, 452) | 328.5 (267, 471) | 335.0 (239, 436) | 302.0 (208, 394) |
TABLE 4
| Active treatment, | Placebo, | |||
|---|---|---|---|---|
| Day 0 | Day 180 | Day 0 | Day 180 | |
|
| ||||
| Mean (SD) | 128.6 (23.7) | 130.0 (22.9) | 120.6 (26.2) | 115.8 (30.4) |
| Median (min, max) | 128.0 (82, 169) | 130.0 (87, 168) | 126.0 (88, 147) | 102.0 (83, 156) |
|
| ||||
| Mean (SD) | 185.8 (23.9) | 204.8 (31.5) | 169.6 (43.5) | 164.8 (33.3) |
| Median (min, max) | 194.0 (142, 220) | 210.0 (142, 260) | 159.0 (124, 236) | 165.0 (123, 210) |
|
| ||||
| Mean (SD) | 314.4 (34.2) | 334.8 (38.9) | 290.2 (68.1) | 280.6 (±59.6) |
| Median (min, max) | 321.0 (252, 375) | 342.0 (272, 380) | 285.0 (212, 383) | 267.0 (222, 349) |
|
| ||||
| Mean (SD) | 13.6 (9.8) | 14.4 (11.9) | 24.2 (10.0) | 13.2 (2.5) |
| Median (min, max) | 12.0 (0, 37) | 11.0 (0, 43) | 20.0 (15, 35) | 14.0 (9, 16) |
|
| ||||
| Mean (SD) | 5.4 (8.8) | 5.8 (6.2) | 2.8 (2.7) | 6.8 (6.4) |
| Median (min, max) | 0.0 (0, 29) | 6.0 (0, 23) | 3.0 (0, 6.0) | 6.0 (0, 17) |
|
| ||||
| Mean (SD) | 19.0 (15.6) | 20.2 (14.5) | 27.0 (10.2) | 20.0 (4.8) |
| Median (min, max) | 13.0 (0, 55) | 15.0 (0, 52) | 20.0 (19, 41) | 22.0 (14, 26) |
|
| ||||
| Mean (SD) | 142.2 (23.1) | 144.5 (24.6) | 144.8 (27.8) | 129.0 (29.4) |
| Median (min, max) | 145.0 (96, 178) | 153.0 (95, 179) | 141.0 (115, 182) | 115.0 (97, 170) |
|
| ||||
| Mean (SD) | 191.3 (28.9) | 210.6 (32.4) | 172.4 (41.2) | 171.6 (38.4) |
| Median (min, max) | 194.0 (142, 238) | 210.0 (145, 269) | 164.0 (130, 236) | 168.0 (129, 227) |
|
| ||||
| Mean (SD) | 333.5 (34.8) | 355.1 (36.3) | 317.2 (68.1) | 300.6 (63.0) |
| Median (min, max) | 334.0 (266, 381) | 357.0 (188, 407) | 305.0 (253, 418) | 283.0 (242, 375) |
TABLE 5
| Sum of hair width | Active treatment, | Placebo, | ||
|---|---|---|---|---|
| Anterior sum of hair width |
|
|
|
|
| Mean (SD) | 8972.6 (1898) | 9408 (1944) | 8861 (2027) | 8719 (2174) |
| Posterior sum of hair width |
|
|
|
|
| Mean (SD) | 11894.4 (2838) | 12 744 (2698) | 12710.1 (2698) | 12312.8 (2671) |
| Total sum of hair width |
|
|
|
|
| Mean (SD) | 20867.1 (3474) | 22152.1 (3709) | 21571.2 (4120) | 21032.8 (4405) |
|
|
|
| ||
| Anterior follicular units |
|
|
|
|
| Mean (SD) | 114.2 (22.0) | 117.5 (22.4) | 115.8 (32.6) | 111.1 (24.7) |
| Posterior follicular units |
|
|
|
|
| Mean (SD) | 113.1 (26.4) | 117.2 (28.3) | 118.1 (25.7) | 115.5 (27.1) |
| Total follicular units |
|
|
|
|
| Mean (SD) | 227.4 (40.4) | 234.7 (37.2) | 233.9 (54.9) | 226.7 (47.3) |
TABLE 6
| Sum of hair width | Active treatment, | Placebo, | ||
|---|---|---|---|---|
| Anterior sum of hair width |
|
|
|
|
| Mean (SD) | 9703.9 (1985) | 10107.3 (1953) | 9322.0 (2133) | 8510.7 (2325) |
| Posterior sum of hair width |
|
|
|
|
| Mean (SD) | 10484.0 (2617) | 10939.6 (3058) | 12746.6 (2981) | 11608.1 (2813) |
| Total sum of hair width |
|
|
|
|
| Mean (SD) | 20187.9 (3695) | 21046.9 (3970) | 22068.6 (4360) | 20118.8 (4759) |
| Follicular units |
|
| ||
| Anterior follicular units |
|
|
|
|
| Mean (SD) | 112.5 (19.7) | 117.6 (21.5) | 117.4 (43.3) | 110.7 (29.1) |
| Posterior follicular units |
|
|
|
|
| Mean (SD) | 99.1 (18.8) | 104.9 (25.6) | 124.9 (29.5) | 112.1 (31.5) |
| Total follicular units |
|
|
|
|
| Mean (SD) | 211.7 (33.9) | 222.5 (37.0) | 242.3 (69.3) | 222.8 (58.7) |
TABLE 7
| Sum of hair width | Active treatment, | Placebo, | ||
|---|---|---|---|---|
| Anterior sum of hair width |
|
|
|
|
| Mean (SD) | 8478.8 (1443) | 8750.4 (1834) | 7970.4 (1461) | 7553.8 (1629) |
| Posterior sum of hair width |
|
|
|
|
| Mean (SD) | 13494.6 (2332) | 14606.6 (2336) | 12692.8 (3339) | 12782.0 (3439) |
| Total sum of hair width |
|
|
|
|
| Mean (SD) | 21973.4 (3006) | 23357.0 (3279) | 20663.2 (4755) | 20335.8 (4875.5) |
TABLE 8
| Rating | Description |
|---|---|
| 7 | Greatly Increased/Improved |
| 6 | Moderately Increased/Improved |
| 5 | Slightly Increased/Improved |
| 4 | No change |
| 3 | Slightly Decreased/Worsened |
| 2 | Moderately Decreased/Worsened |
| 1 | Greatly Decreased/Worsened |
TABLE 9
| Active( | Placebo( | |
|---|---|---|
|
| ||
| Greatly improved | 1 (2.5) | — |
| Moderately improved | 12 (30) | — |
| Slightly improved | 19 (47.5) | 6 (30) |
| No change | 4 (10) | 9 (45) |
| Slightly worsened | 4 (10) | 4 (20) |
| Moderately worsened | 1 (5) | |
| Greatly worsened | ||
|
| ||
| Greatly increased | ||
| Moderately increased | 8 (20) | 1 (5) |
| Slightly increased | 20 (50) | 4 (20) |
| No change | 6 (15) | 7 (35) |
| Slightly decreased | 6 (15) | 6 (30) |
| Moderately decreased | 2 (10) | |
| Greatly decreased | ||
TABLE 10
| Hair/skin characteristic, | Active ( | Placebo ( | ||||
|---|---|---|---|---|---|---|
| Day 56 | Day 90 | Day 180 | Day 56 | Day 90 | Day 180 | |
| Hair shedding | 17 (42.5) | 16 (40) | 19 (47.5) | 11 (55) | 13 (65) | 14 (70) |
| Overall hair growth | 20 (50) | 28 (70) | 28 (70) | 9 (45) | 10 (50) | 13 (65) |
| Overall hair volume | 13 (32.5) | 22 (55) | 27 (67.5) | 5 (25) | 10 (50) | 12 (60) |
| Scalp coverage | 15 (37.5) | 21 (52.5) | 24 (60) | 4 (20) | 9 (45) | 9 (45) |
| Hair thickness | 15 (37.5) | 17 (42.5) | 25 (62.5) | 5 (25) | 7 (35) | 7 (35) |
| Hair fullness | 18 (45) | 19 (47.5) | 25 (62.5) | 5 (25) | 7 (35) | 11 (55) |
| Hair quality | 12 (30) | 25 (62.5) | 21 (52.5) | 7 (35) | 9 (45) | 11 (55) |
| Hair shine/gloss | 11 (27.5) | 17 (42.5) | 14 (35) | 5 (25) | 8 (40) | 9 (45) |
| Hair strength | 18 (45) | 22 (55) | 19 (47.5) | 8 (40) | 10 (50) | 11 (55) |
| Hair softness | 16 (40) | 22 (55) | 14 (35) | 6 (30) | 6 (30) | 10 (50) |
| Amount of noticeable new hair | 14 (35) | 22 (55) | 25 (62.5) | 4 (20) | 10 (50) | 12 (60) |
| Hair growth rate | 17 (42.5) | 22 (55) | 23 (57.5) | 4 (2) | 10 (50) | 13 (65) |
| Hair growth on top of head | 17 (42.5) | 21 (52.5) | 26 (65) | 6 (30) | 10 (50) | 8 (40) |
| Hair growth of hairline | 13 (32.5) | 13 (32.5) | 19 (47.5) | 4 (20) | 8 (40) | 11 (55) |
| Hair length | 14 (35) | 20 (50) | 23 (57.5) | 5 (25) | 7 (35) | 9 (45) |
| Ease of styling | 11 (27.5) | 13 (32.5) | 14 (35) | 5 (25) | 5 (25) | 5 (25) |
| Hair Moisture | 12 (30) | 15 (37.5) | 13 (32.5) | 9 (45) | 5 (25) | 5 (25) |
| Overall hair appearance | 18 (45) | 22 (55) | 24 (60) | 12 (60) | 11 (55) | 12 (60) |
| Growth of eyebrow hair | 8 (20) | 14 (35) | 14 (35) | 20 (100) | 4 (20) | 4 (20) |
| Thickness of eyebrow hair | 7 (17.5) | 13 (32.5) | 14 (35) | 20 (100) | 20 (100) | 4 (20) |
| Growth of eyelash hair | 2 (5) | 6 (15) | 5 (12.5) | 1 (5) | 1 (5) | 3 (15) |
| Thickness of eyelashes | 1 (2.5) | 4 (10) | 3 (7.5) | 1 (5) | 1 (5) | 3 (15) |
| Skin smoothness and fine lines | 4 (10) | 6 (15) | 4 (10) | 6 (30) | 4 (20) | 6 (30) |
| Overall skin health | 5 (12.5) | 4 (10) | 4 (10) | 5 (25) | 6 (30) | 8 (40) |
References
- Types and Characteristics of Hair Across the Clobe: Results of a Multinational Study on 19,461 Individuals Clinical, Cosmetic and Investigational Dermatology, 2025
- Male and Female Pattern Hair Loss Australian Prescriber, 2025
- Efficacy and Safety of Oral Spironolactone for Female Pattern Hair Loss in Premenopausal Women: A Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐Group Pilot Study International Journal of Womens Dermatology, 2025
- The Use of Serenoa Repens (Saw Palmetto) in Hair Care Products Biomedical Journal of Scientific & Technical Research, 2019
- Natural Hair Supplement: Friend or Foe? Saw Palmetto, a Systematic Review in Alopecia Skin Appendage Disorders, 2020
- Determination of the Potency of a Novel Saw Palmetto Supercritical CO2 Extract (SPSE) for 5α‐Reductase Isoform II Inhibition Using a Cell‐Free in Vitro Test System Research and Reports in Urology, 2016
- Clinical Outcome of the Topical Application of a Novel Hair Growth Ingredient, USPlus DERM, in Men and Women Journal of Clinical and Investigative Dermatology, 2025
- 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 Journal of Cosmetic Dermatology, 2025
- Reliability of Hamilton‐Norwood Classification International Journal of Trichology, 2009
- Common Causes of Hair Loss ‐ Clinical Manifestations, Trichoscopy and Therapy Journal of the European Academy of Dermatology and Venereology: JEADV, 2021
- Lipid Profile and 5α‐Reductase Inhibition Activity of Proprietary Ultrahigh‐Pressure Supercritical Carbon Dioxide and Hexane Saw Palmetto Extracts International Journal of Urology, 2023
- A Proprietary Lipidosterolic Extract of Serenoa Repens Promotes Hair Growth Through Mechanisms That Extend Beyond 5‐Alpha Reductase Inhibition: Insights From Human Hair Follicle Organ Culture International Journal of Cosmetic Science, 2025
- Oral and Topical Administration of a Standardized Saw Palmetto Oil Reduces Hair Fall and Improves the Hair Growth in Androgenetic Alopecia Subjects ‐ A 16‐Week Randomized, Placebo‐Controlled Study Clinical, Cosmetic and Investigational Dermatology, 2023
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