Safety and Efficacy of a Hydrolyzed Collagen Formulation (HYCOS) for Facial Skin Elasticity and Wrinkles: A Randomized, Double-Blind, Placebo-Controlled Trial

IF 3.5 4区 医学 Q2 DERMATOLOGY
Sutthinee Wisutthathum, Preeyanuch Pimjuk, Nitina Yeesibsean, Katechan Jampachaisri, Panlop Chakkavittumrong, Warisara Pasri, Pichet Kittikun, Supaporn Tuanthai, Thanwarat Suebwongfag, Tanyarat Sutti, Jew Puay Tay, Anjana Fuangchan, Neti Waranuch
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引用次数: 0

Abstract

Background

Oral collagen supplements are widely marketed for improving skin aging parameters, however, high-quality clinical evidence for multi-ingredient formulations in Asian populations remains limited.

Aims

This study evaluated the safety and efficacy of a hydrolyzed collagen formulation (HYCOS) on facial skin parameters in healthy Thai volunteers.

Methods

A 12-week double-blind, randomized placebo-controlled trial was conducted in 140 Thai participants aged 30–60 with mild-to-moderate facial wrinkles. Participants were received either HYCOS collagen (hydrolyzed collagen with Glutathione and Vitamin E) or a placebo drink. Skin hydration, elasticity, and crow's feet wrinkle roughness were measured using Corneometer, Cutometer, and 3D skin imaging (PRIMOSCR), respectively. Dermatologist wrinkle grading and participant self-assessment were collected. Safety was evaluated through adverse event monitoring and blood/urine biochemical testing.

Results

A total of 135 participants completed the study (test product, n = 66; placebo, n = 69). After 12 weeks, both groups showed significant increases in skin hydration (p < 0.001), with no between-group difference. The test product group demonstrated greater improvements in skin elasticity; gross elasticity (R2), net elasticity (R5), and overall elasticity (R7) compared with placebo (p < 0.05). Crow's feet wrinkle roughness analysis revealed significantly greater reductions in wrinkle roughness in the test product group than in the placebo group at week 12. No product-related adverse events were observed, and laboratory values remained within normal ranges.

Conclusion

Daily supplementation with HYCOS collagen formula for 12 weeks was safe and well tolerated, with significant improvements in skin elasticity and wrinkle roughness. Increases in skin hydration were observed in both groups, suggesting that this effect may be influenced by hydration-related or behavioural factors rather than the supplement alone. Overall, HYCOS supplementation may provide beneficial effects on skin aging parameters in healthy adults.

Trial Registration

Thai Clinical Trials Registry: TCTR20250619006

水解胶原蛋白配方(HYCOS)对面部皮肤弹性和皱纹的安全性和有效性:一项随机、双盲、安慰剂对照试验
口服胶原蛋白补充剂被广泛用于改善皮肤老化参数,然而,在亚洲人群中,多成分配方的高质量临床证据仍然有限。目的本研究评估水解胶原蛋白制剂(HYCOS)对泰国健康志愿者面部皮肤参数的安全性和有效性。方法对140名年龄在30-60岁、面部有轻度至中度皱纹的泰国参与者进行为期12周的双盲、随机安慰剂对照试验。参与者接受HYCOS胶原蛋白(谷胱甘肽和维生素E水解胶原蛋白)或安慰剂饮料。分别使用Corneometer、Cutometer和3D皮肤成像(PRIMOSCR)测量皮肤水合度、弹性和鱼尾纹粗糙度。收集皮肤科医生的皱纹评分和参与者的自我评估。通过不良事件监测和血/尿生化检测评估安全性。结果共有135名参与者完成了研究(试验产品,n = 66;安慰剂,n = 69)。12周后,两组皮肤含水量均显著增加(p < 0.001),组间无差异。测试产品组在皮肤弹性方面表现出更大的改善;与安慰剂相比,总弹性(R2)、净弹性(R5)和总弹性(R7) (p < 0.05)。鱼尾纹皱纹粗糙度分析显示,在第12周,测试产品组的皱纹粗糙度明显大于安慰剂组。未观察到与产品相关的不良事件,实验室值保持在正常范围内。结论每日补充HYCOS胶原蛋白配方12周是安全且耐受性良好的,皮肤弹性和皱纹粗糙度均有显著改善。在两组中都观察到皮肤水合作用的增加,这表明这种效果可能受到水合作用相关因素或行为因素的影响,而不仅仅是补充剂。总的来说,补充HYCOS可能对健康成年人的皮肤衰老参数有有益的影响。泰国临床试验注册中心:TCTR20250619006
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来源期刊
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.
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