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Double-blind randomized placebo-controlled study of the efficacy and safety of hair loss prevention shampoo containing salicylic acid, panthenol, and niacinamide in alopecia patients

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Abstract

Purpose

This double-blind randomized placebo-controlled clinical study aimed to investigate the efficacy and safety of hair loss prevention shampoo with salicylic acid (0.2%), panthenol (0.2%), and niacinamide (0.1%) in alopecia patients.

Methods

A total of 42 subjects completed the 24-week clinical study. A series of clinical examinations, counting of the number of hairs number on the crown, and visual and subject survey evaluations were performed at baseline and 8, 16, and 24 weeks after use to evaluate the efficacy and safety of the shampoo for preventing hair loss.

Results

The primary endpoint was the number of hairs on the crown, which showed a significantly greater increase (17.76%) in the treatment group than in the placebo group at 24 weeks after use (p < 0.05). In the intention-to-treat population, the secondary endpoint, visual evaluation of hair loss symptoms, the crown, the line of forelock, and hair thickness also showed significantly greater increases in the treatment group than in the placebo group (p < 0.05) at 24 weeks after use. Safety evaluations confirmed no abnormal symptoms in the experimental and placebo groups.

Conclusions

Therefore, this study suggests that shampoo treatment can help prevent hair loss in patients with alopecia.

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Acknowledgements

This project did not receive any specific grant from funding agencies.

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Correspondence to Jae-Suk Choi.

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Conflict of interest

Hee-Taek Kim, Hye-Su Park, Yong-Min Kim, In-Chul Lee, Sang-Jun Lee, and Jae-Suk Choi declare that they have no conflict of interest.

Ethical approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This clinical research was approved by the Institutional Review Board of Semyung University Korean Medicine Hospital (Approval no. SMJOH SMJOH-18-21).

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Appendix 1

Appendix 1

See Table 9.

Table 9 Evaluation of scalp safety, including questionnaire evaluation of subjective irritation by the research subjects and objective irritation by the researcher

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Kim, HT., Park, HS., Kim, YM. et al. Double-blind randomized placebo-controlled study of the efficacy and safety of hair loss prevention shampoo containing salicylic acid, panthenol, and niacinamide in alopecia patients. Toxicol. Environ. Health Sci. 14, 173–185 (2022). https://doi.org/10.1007/s13530-022-00126-9

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