Instrumental Assessment of a Homocysteic Acid-containing Chemical Skin Biostimulator in the Management of Photoaged Mature Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
研究概览
简要总结
This study evaluated whether a chemical skin biostimulator containing ammonium trichloroacetate, homocysteic acid, phytic acid and citric acid can improve signs of photoaged skin in women with mature skin. Twenty-five women received four treatment sessions two weeks apart, followed by a home-care skincare regimen. Skin firmness, wrinkles, skin texture, hydration, sebum production and, in participants with hyperpigmentation, skin tone uniformity were measured before treatment and at 2 and 12 weeks after the treatment series to determine whether the biostimulator produces lasting improvement in photoaged skin without the downtime associated with traditional chemical peels.
详细描述
This was a single-arm, prospective, open-label study conducted at a single academic centre to assess the clinical and instrumental effects of a chemical skin biostimulator (PRX plus, WiQO, Trieste, Italy) on facial photoaging. The intervention combines ammonium trichloroacetate (ATCA), a controlled-penetration TCA derivative intended to stimulate dermal fibroblast activity and collagen remodelling, with homocysteic acid (HoA), a novel antioxidant and NMDA-receptor-modulating molecule proposed to influence keratinocyte differentiation, epidermal barrier function and melanocyte activity, together with low concentrations of phytic and citric acids providing mild keratolytic and antioxidant effects. Treatment consisted of a standardised four-session protocol (three product layers per session) applied to defined facial regions of interest, combined with a daytime regenerating cream, a nighttime glycolic-acid-containing fluid, and, in participants with hyperpigmentation, a twice-daily lightening serum. Outcomes were assessed instrumentally using Cutometer (skin viscoelasticity), Antera 3D (wrinkle volume and surface texture), corneometry and sebumetry (hydration and sebum), and grey-level co-occurrence matrix (GLCM) analysis of standardised cross-polarised photographs (skin tone homogeneity in the hyperpigmented subgroup), at baseline, 2 weeks after the final session, and 12 weeks after completion of the treatment series, to characterise both the immediate and sustained effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 39 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Fitzpatrick skin phototype II
- •Age 39-69 years
- •Clinical signs of facial photoaging
- •Some participants had hyperpigmentation (melasma or post-inflammatory hyperpigmentation)
排除标准
- •Pregnancy or breastfeeding
- •Ongoing hormone therapy
- •Systemic corticosteroid use within 3 months prior to inclusion
- •Topical retinoid use within 1 month, or oral retinoid use within 6 months, prior to treatment
- •Chemical peel procedures within 1 month prior to treatment
- •Use of arbutin and/or hydroquinone within 3 months prior to treatment
- •Laser-based treatments within 3 months prior to treatment
- •Active inflammatory dermatoses
- •Autoimmune diseases
- •Renal impairment
研究组 & 干预措施
Chemical skin biostimulator (ATCA/HoA) plus home-care regimen
Women with clinical signs of facial photoaging received four sessions, at 14-day intervals, of a topical chemical skin biostimulator containing ammonium trichloroacetate (ATCA), homocysteic acid (HoA), phytic acid and citric acid (PRX plus, WiQO), followed by a standardised home-care regimen consisting of a regenerating cream (morning), a glycolic-acid-containing fluid (evening), and, in participants with hyperpigmentation, a lightening serum applied twice daily to affected areas.
干预措施: Chemical skin biostimulation with ammonium trichloroacetate and homocysteic acid (Procedure)
结局指标
主要结局
Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Skin viscoelasticity assessed by Cutometer, reported as gross elasticity (R2), net elasticity (R5) and biological elasticity (R7); each is a dimensionless ratio ranging from 0 to 1, with higher values indicating greater skin elasticity.
Change From Baseline in Wrinkle Volume (Antera 3D)
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Wrinkle volume at the nasolabial folds, glabellar lines, forehead lines, and crow's feet, measured in mm³ by Antera 3D three-dimensional imaging.
Change From Baseline in Skin Texture Score (Antera 3D)
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
A proprietary continuous index from the Antera 3D imaging software (Miravex) reflecting skin surface irregularity, with no manufacturer-published fixed range; observed values in this study ranged from approximately 20 to 55, with higher values indicating rougher skin.
Change From Baseline in Skin Roughness (Antera 3D, Ra)
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Arithmetic roughness (Ra), measured in micrometres (µm) by Antera 3D.
Change From Baseline in Maximum Wrinkle Height (Antera 3D)
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Maximum surface height of wrinkles, measured in millimetres (mm) by Antera 3D.
Change From Baseline in Skin Hydration
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Skin hydration measured by corneometry (arbitrary corneometer units).
Change From Baseline in Sebum Secretion
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Sebum secretion measured by sebumetry.
Change From Baseline in Skin Tone Contrast (GLCM) in Participants With Hyperpigmentation
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Grey-level co-occurrence matrix (GLCM) contrast index in the hyperpigmented subgroup (n=14), assessed from standardised cross-polarised photographs.
Change From Baseline in Skin Tone Homogeneity (GLCM) in Participants With Hyperpigmentation
时间窗: Baseline, 2 weeks, and 12 weeks after the treatment series
Grey-level co-occurrence matrix (GLCM) homogeneity index (range 0-1; higher values indicate greater uniformity) in the hyperpigmented subgroup (n=14).
次要结局
- Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness(Immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals), compared with baseline)
- Satisfaction With Wrinkle-Reduction and Firming Effects(Immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals))
- Proportion of Participants Satisfied With Facial and Neck Appearance(Baseline and immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals))
- Percentage Retention of Maximal Improvement in Wrinkle Volume and Skin Texture at 12 Weeks(2 weeks and 12 weeks after the treatment series)