Intervention: Nutrafol Skin (n = 47) or placebo (n = 45).
Methods: Subjects visited the clinic for evaluation at baseline, Week 4, Week 8 and Week 12. Evaluations included: the Investigator Global Assessment (IGA) of acne severity; blinded investigator assessments of the skin including post-inflammatory erythema, acne scarring and overall skin appearance; skin hydration levels; self-perception questionnaires.
Study Duration: 12 weeks
Eligibility Criteria:
For more, plus the exclusion criteria, see:
After 12 weeks of treatment, Nutrafol Skin significantly improved the mean Investigator Global Assessment (IGA) score of acne severity, relative to placebo (P = 0.02).
Closer inspection of the IGA data revealed that the percentage of subjects who achieved an IGA rating of 0/1 (clear/almost clear) was 36% in the Nutrafol Skin group vs. 18% in the placebo group at the 8-week timepoint (P<0.05), and 44% in the Nutrafol Skin group vs. 13% in the placebo group at 12 weeks (P<0.01).
Furthermore, the percentage of subjects improving over the course of the study was significantly greater in the Nutrafol Skin group, relative to placebo: 53% of the Nutrafol Skin group vs. 27% of the placebo group improved their ratings after 12 weeks of treatment (P<0.01).
Changes in Investigator Global Assessment (IGA) of acne severity. Left: Percentage of subjects achieving clear/almost clear (IGA 0/1). Right: Percentage of subjects with improved IGA ratings. *P<0.05 and **P<0.01 compared to placebo. Adapted from Draelos et al., A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. Journal of Cosmetic Dermatology (2025), 24(5):e70220.
Inflammatory lesion count was reduced by 56.2% in the Nutrafol Skin group at the 12-week timepoint relative to baseline (P<0.01). Although this was not statistically different compared to the placebo group, the mean percent decrease in inflammatory lesions trended larger in the Nutrafol Skin group than in the placebo group at each study timepoint.
Non-inflammatory lesion count was reduced by 48.1% in the Nutrafol Skin group at 12-weeks relative to baseline (P<0.01). Although the percentage decrease over time was greater in the Nutrafol Skin group relative to placebo, the difference between the groups did not reach statistical significance.
Changes in inflammatory and non-inflammatory lesions. Left: Percent change in inflammatory lesions. Right: Percent change in non-inflammatory lesions. **P<0.01 compared to baseline. Adapted from Draelos et al., A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. Journal of Cosmetic Dermatology (2025), 24(5):e70220.
Blinded investigator skin assessments revealed that a significantly greater proportion of subjects in the Nutrafol Skin group exhibited improvements in post-inflammatory erythema (P<0.01), acne scarring (P<0.05), smoothness (P<0.05), softness (P<0.05) and overall skin appearance (P<0.05) when compared to placebo after 12 weeks of treatment.
Percentage of subjects achieving positive ratings (0/1) in skin parameters. PIE = post-inflammatory erythema; PIH = post-inflammatory hyperpigmentation. *P<0.05 and **P<0.01 compared to placebo. Adapted from Draelos et al., A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. Journal of Cosmetic Dermatology (2025), 24(5):e70220.
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