A Randomized Double-Blind Controlled Evaluation of the Therapeutic Benefits of an Herbal Lip Hydrant.

OBJECTIVE

Dry and chapped lips adversely affect both lip structure and function, yet there is no established gold standard for their treatment. Herbal extracts present a promising alternative due to their natural properties, though their therapeutic potential for lip care remains underexplored. This study aims to develop and clinically evaluate a novel lip hydrant formulated with polyherbal extracts, with the objective of offering an effective solution for managing dry and chapped lips.

METHODS

Six herbal extracts and eight mixtures, consisting of at least three herbal extracts, were evaluated for cytotoxicity using the MTT assay in HaCaT cells. The essential molecular markers were examined by western blot analysis and immunofluorescence assay. The selected mixture was formulated into lip hydrant and tested in a randomized, double-blind, controlled clinical trial. The 66 Thai participants with dry lip concerns were randomly assigned into two groups. Each participant applied either the lip hydrant (test group) or petroleum gel (control group) once daily for 28 days. Clinical assessments were performed at baseline and on day 28 post-application. The lip conditions, lip texture wrinkles, and hemoglobin levels were measured. Participant assessments included ratings of lip dryness, appearance, and product satisfaction.

RESULTS

The herbal extracts demonstrated potential in strengthening cell adherence, providing antioxidant effect, and inducing self-renewal. The Mix2 shows the most promising activity, increasing adherent protein and stemness properties, and was selected as the active ingredient for the clinical trial. In the trial, both the test and control groups experienced a significant reduction in lip roughness by day 28 compared to baseline (p < 0.05). However, the test group exhibited a significantly greater reduction in chapped lips than the control group (p < 0.05). No significant differences were found between the groups in terms of lip texture, wrinkle levels, or hemoglobin levels. Notably, both groups showed significant improvements in perceived lip dryness by day 28 (p < 0.001).

CONCLUSION

The study findings support the therapeutic potential of the novel polyherbal lip hydrant in improving lip hydration, reducing roughness, and alleviating chapped lips (ClinicalTrials.gov ID: NCT06475482).

© 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.