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

IF 2.5 4区医学 Q2 DERMATOLOGY Journal of Cosmetic Dermatology Pub Date : 2025-02-27 DOI:10.1111/jocd.70041

Pimchanok Sutthiboonyapan, Nicharat Sriratanasak, Bhurichaya Innets, Nachon Angkanaporn, Parinnapa Suntornchot, Warunya Panyain, Thantrira Porntaveetus, Paswach Wiriyakijja, Pithi Chanvorachote

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Abstract

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).

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一种草药唇栓治疗效果的随机双盲对照评价

目的嘴唇干燥和干裂对嘴唇的结构和功能都有不利影响，但目前还没有治疗嘴唇干燥和干裂的金标准。草药提取物具有天然特性，是一种很有前景的替代品，但其在唇部护理方面的治疗潜力仍未得到充分开发。本研究旨在开发一种由多种草本植物提取物配制而成的新型润唇膏，并对其进行临床评估，目的是为护理干燥和干裂的嘴唇提供一种有效的解决方案。方法在 HaCaT 细胞中使用 MTT 法评估六种草药提取物和八种至少由三种草药提取物组成的混合物的细胞毒性。通过 Western 印迹分析和免疫荧光试验检测了重要的分子标记。选定的混合物被配制成润唇膏，并在随机、双盲、对照临床试验中进行了测试。66 名患有唇干问题的泰国参与者被随机分配到两组。每位参与者在 28 天内每天涂抹一次唇部润肤霜（试验组）或石油凝胶（对照组）。在基线和使用后的第 28 天进行临床评估。对唇部状况、唇纹皱纹和血红蛋白水平进行了测量。参与者的评估包括对嘴唇干燥程度、外观和产品满意度的评分。结果中药提取物在加强细胞粘附性、抗氧化作用和诱导自我更新方面表现出潜力。Mix2 显示出最有前景的活性，它能增加附着蛋白和干性特性，因此被选为临床试验的活性成分。在试验中，与基线相比，试验组和对照组的嘴唇粗糙度在第 28 天时都有显著下降（p < 0.05）。不过，试验组嘴唇干裂的减少程度明显高于对照组（p < 0.05）。测试组和对照组在嘴唇质地、皱纹程度和血红蛋白水平方面没有明显差异。值得注意的是，到第 28 天时，两组的唇部干燥感都有明显改善（p < 0.001）。结论研究结果支持新型多草本润唇膏在改善唇部保湿、减少粗糙度和缓解唇部干裂方面的治疗潜力（ClinicalTrials.gov ID：NCT06475482）。

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来源期刊

Journal of Cosmetic Dermatology DERMATOLOGY-

CiteScore

4.30

自引率

13.00%

发文量

818

审稿时长

>12 weeks

期刊介绍： The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.