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一项外用类视黄醛(油醇视黄醛)与视黄醇的前瞻性、双盲、随机对照临床试验。

A prospective, double-blinded, randomized head-to-head clinical trial of topical adapinoid (oleyl adapalenate) versus retinol.

作者信息

Nguyen Nhi, Afzal Nasima, Min Mildred, Ahmad Nabeel, Afzal Laila, Burney Waqas, Chambers Cindy J, Sivamani Raja K

机构信息

Integrative Skin Science and Research Sacramento California USA.

California Northstate University College of Medicine Elk Grove California USA.

出版信息

Skin Health Dis. 2024 Nov 4;4(6):e469. doi: 10.1002/ski2.469. eCollection 2024 Dec.

DOI:10.1002/ski2.469
PMID:39624736
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11608876/
Abstract

BACKGROUND

Retinoids, such as retinol, are widely investigated and utilized in skin care products as a treatment for photoaging but their use is limited by tolerability. Adapinoid (oleyl adapalenate, OA) is a novel third generation retinoid that is a pro-drug of adapalene, but there is little research on its effects on photoaging or its tolerability.

OBJECTIVES

The purpose of this study is to compare the effects and tolerability of OA 0.5% to retinol 0.5% cream regarding visible signs of facial photoaging including facial wrinkles, fine lines and pigmentation.

METHODS

In this 12-week, double-blind, randomized clinical trial, 48 eligible participants were recruited and enroled from the Greater Sacramento region. The study consisted of a baseline and follow-up visits at weeks 4, 8 and 12. Participants were randomized to receive either topical OA 0.5% or retinol 0.5% for 12 weeks. The primary outcome was changes in the appearance of wrinkle severity at 12 weeks. Secondary outcome measures include changes in erythema, skin pigmentation, skin hydration and transepidermal water loss (TEWL).

RESULTS

OA improved wrinkle severity by 9.45% ( < 0.0001) at week 12, whereas retinol improved wrinkle severity by 4.11% ( < 0.001) compared to baseline. When comparing the two treatment groups at week 12, the OA group improved significantly more than the retinol group ( = 0.001). OA decreased pigment intensity at week 12 by 3.88% ( < 0.0001), whereas retinol decreased pigment intensity by 3.15% ( < 0.03) compared to baseline. OA-based improvement in pigment intensity at week 12 was not significantly different from retinol ( = 0.62). OA reduced facial erythema by 13.39% ( < 0.05) at week 12, whereas the retinol group did not have a significant change. OA use led to a 14.92% decrease in TEWL by week 12 ( = 0.07), whereas the retinol group had no significant change. OA was better tolerated than retinol when assessed at all follow-up visits.

CONCLUSIONS

OA 0.5% is superior to retinol 0.5% in improving wrinkle severity and similar in improvement of pigment intensity. OA is better tolerated than retinol. Overall, the use of OA as a precursor to adapalene may be an effective method to improving the tolerability of retinoids while maintaining efficacy.

TRIAL REGISTRATION

This study was registered on www.clinicaltrials.gov (NCT05778760).

摘要

背景

维甲酸类药物,如视黄醇,在护肤品中作为光老化的治疗方法被广泛研究和应用,但其使用受到耐受性的限制。阿达帕林oid(油酸阿达帕林酯,OA)是一种新型的第三代维甲酸类药物,是阿达帕林的前体药物,但关于其对光老化的影响或耐受性的研究较少。

目的

本研究的目的是比较0.5% OA乳膏与0.5%视黄醇乳膏对面部光老化可见迹象(包括面部皱纹、细纹和色素沉着)的效果和耐受性。

方法

在这项为期12周的双盲、随机临床试验中,从大萨克拉门托地区招募并纳入了48名符合条件的参与者。该研究包括基线访视以及第4、8和12周的随访。参与者被随机分配接受局部0.5% OA或0.5%视黄醇治疗12周。主要结局是12周时皱纹严重程度外观的变化。次要结局指标包括红斑、皮肤色素沉着、皮肤水合作用和经表皮水分流失(TEWL)的变化。

结果

与基线相比,OA在第12周时使皱纹严重程度改善了9.45%(P<0.0001),而视黄醇使皱纹严重程度改善了4.11%(P<0.001)。在第12周比较两个治疗组时,OA组的改善明显大于视黄醇组(P = 0.001)。与基线相比,OA在第12周时使色素强度降低了3.88%(P<0.0001),而视黄醇使色素强度降低了3.15%(P<0.03)。OA在第12周时色素强度的改善与视黄醇没有显著差异(P = 0.62)。OA在第12周时使面部红斑减少了13.39%(P<0.05),而视黄醇组没有显著变化。到第12周时,使用OA使TEWL降低了14.92%(P = 0.07),而视黄醇组没有显著变化。在所有随访访视中评估时,OA的耐受性优于视黄醇。

结论

0.5% OA在改善皱纹严重程度方面优于0.5%视黄醇,在改善色素强度方面相似。OA的耐受性优于视黄醇。总体而言,将OA用作阿达帕林的前体可能是一种在保持疗效的同时提高维甲酸类药物耐受性的有效方法。

试验注册

本研究在www.clinicaltrials.gov上注册(NCT05778760)。

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