PDF(Pubmed)
Abstract：
UNASSIGNED: A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of VerbasnolTM [Rehmannia glutinosa Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris.
UNASSIGNED: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days. The primary outcome was a change in acne severity measured by the GAGS compared to the placebo on day 56. The secondary outcomes were changes in the number of inflammatory acne lesions, facial sebum secretion, quality of life, local pain and itching, skin wrinkle severity, and other skin characteristics, including radiance, luminosity, smoothness, texture, firmness, and hydration. Additionally, the percentage of responders and global tolerability and efficacy were evaluated.
UNASSIGNED: The mean GAGS score was reduced by 21.72% and 14.20% on day 28 in RGLE (n=10) and placebo groups (n=12), respectively, which further reduced in both groups on day 56. The RGLE group reported better improvement in other skin characteristics on day 56. No safety or tolerability concerns were reported for the extract. RGLE reduced acne and improved the skin quality in females compared to placebo as early as 28 days of supplementation.
UNASSIGNED: RGLE supplementation at a dose of 100 mg/day has provided a clinically relevant decrease in acne severity and improved the skin hydration and quality of life of the participants with acne after 56 days of dose administration.
UNASSIGNED: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days. The primary outcome was a change in acne severity measured by the GAGS compared to the placebo on day 56. The secondary outcomes were changes in the number of inflammatory acne lesions, facial sebum secretion, quality of life, local pain and itching, skin wrinkle severity, and other skin characteristics, including radiance, luminosity, smoothness, texture, firmness, and hydration. Additionally, the percentage of responders and global tolerability and efficacy were evaluated.
UNASSIGNED: The mean GAGS score was reduced by 21.72% and 14.20% on day 28 in RGLE (n=10) and placebo groups (n=12), respectively, which further reduced in both groups on day 56. The RGLE group reported better improvement in other skin characteristics on day 56. No safety or tolerability concerns were reported for the extract. RGLE reduced acne and improved the skin quality in females compared to placebo as early as 28 days of supplementation.
UNASSIGNED: RGLE supplementation at a dose of 100 mg/day has provided a clinically relevant decrease in acne severity and improved the skin hydration and quality of life of the participants with acne after 56 days of dose administration.
摘要：
■双盲，安慰剂对照,随机化，概念验证试验旨在评估VerbasnolTM[地黄叶基提取物（RGLE）]在女性中的疗效和安全性，中度至重度寻常痤疮。
■22名年龄在18至35岁之间的中度至重度痤疮，全球痤疮分级系统（GAGS）评分为19至38的女性被纳入研究，并以1：1的比例随机分配，早餐后口服1粒RGLE胶囊（100mg/天）或安慰剂56天。主要结果是在第56天与安慰剂相比，通过GAGS测量的痤疮严重程度的变化。次要结果是炎性痤疮病变数量的变化，面部皮脂分泌，生活质量,局部疼痛和瘙痒，皮肤皱纹严重程度，和其他皮肤特征，包括辐射,光度,平滑度,纹理,坚定,和水合作用。此外,评估了应答者的百分比以及总体耐受性和疗效.
■在RGLE（n=10）和安慰剂组（n=12）第28天，平均GAGS评分分别降低了21.72％和14.20％，分别,在第56天，两组进一步减少。RGLE组在第56天报告了其他皮肤特征的更好改善。未报告提取物的安全性或耐受性问题。早在补充28天，与安慰剂相比，RGLE减少了女性的痤疮并改善了皮肤质量。
■剂量为100mg/天的RGLE补充剂在56天的剂量给药后，临床上可降低痤疮严重程度，并改善痤疮参与者的皮肤水合作用和生活质量。
■22名年龄在18至35岁之间的中度至重度痤疮，全球痤疮分级系统（GAGS）评分为19至38的女性被纳入研究，并以1：1的比例随机分配，早餐后口服1粒RGLE胶囊（100mg/天）或安慰剂56天。主要结果是在第56天与安慰剂相比，通过GAGS测量的痤疮严重程度的变化。次要结果是炎性痤疮病变数量的变化，面部皮脂分泌，生活质量,局部疼痛和瘙痒，皮肤皱纹严重程度，和其他皮肤特征，包括辐射,光度,平滑度,纹理,坚定,和水合作用。此外,评估了应答者的百分比以及总体耐受性和疗效.
■在RGLE（n=10）和安慰剂组（n=12）第28天，平均GAGS评分分别降低了21.72％和14.20％，分别,在第56天，两组进一步减少。RGLE组在第56天报告了其他皮肤特征的更好改善。未报告提取物的安全性或耐受性问题。早在补充28天，与安慰剂相比，RGLE减少了女性的痤疮并改善了皮肤质量。
■剂量为100mg/天的RGLE补充剂在56天的剂量给药后，临床上可降低痤疮严重程度，并改善痤疮参与者的皮肤水合作用和生活质量。
