Homocysteic Acid Biostimulator for Photoaged Facial Skin
2026年7月22日 更新者：Medical University of Silesia
Instrumental Assessment of a Homocysteic Acid-containing Chemical Skin Biostimulator in the Management of Photoaged Mature Skin
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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sosnowiec、ポーランド
- Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Female, Fitzpatrick skin phototype II
- Age 39-69 years
- Clinical signs of facial photoaging
- Some participants had hyperpigmentation (melasma or post-inflammatory hyperpigmentation)
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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A four-session chemical skin biostimulation procedure using a topical formulation containing ammonium trichloroacetate (ATCA), homocysteic acid (HoA), phytic acid and citric acid (PRX plus, WiQO, Trieste, Italy).
At each session, three product layers were applied to predefined facial areas (forehead, nose, cheeks, chin, upper lip) with massage until absorption, followed by cold-water rinse.
Sessions were repeated at 14-day intervals.
Participants additionally followed a standardised home-care regimen: a regenerating shea-butter cream each morning, a glycolic-acid-containing fluid each evening, and, for participants with hyperpigmentation, a lightening serum applied twice daily to affected areas, together with daily broad-spectrum sunscreen (SPF 50+).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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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.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Wrinkle Volume (Antera 3D)
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Wrinkle volume at the nasolabial folds, glabellar lines, forehead lines, and crow's feet, measured in mm³ by Antera 3D three-dimensional imaging.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Skin Texture Score (Antera 3D)
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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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.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Skin Roughness (Antera 3D, Ra)
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Arithmetic roughness (Ra), measured in micrometres (µm) by Antera 3D.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Maximum Wrinkle Height (Antera 3D)
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Maximum surface height of wrinkles, measured in millimetres (mm) by Antera 3D.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Skin Hydration
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Skin hydration measured by corneometry (arbitrary corneometer units).
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Sebum Secretion
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Sebum secretion measured by sebumetry.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Skin Tone Contrast (GLCM) in Participants With Hyperpigmentation
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Grey-level co-occurrence matrix (GLCM) contrast index in the hyperpigmented subgroup (n=14), assessed from standardised cross-polarised photographs.
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Baseline, 2 weeks, and 12 weeks after the treatment series
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Change From Baseline in Skin Tone Homogeneity (GLCM) in Participants With Hyperpigmentation
時間枠：Baseline, 2 weeks, and 12 weeks after the treatment series
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Grey-level co-occurrence matrix (GLCM) homogeneity index (range 0-1; higher values indicate greater uniformity) in the hyperpigmented subgroup (n=14).
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Baseline, 2 weeks, and 12 weeks after the treatment series
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness
時間枠：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
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Participants' perceived change in facial appearance, neck appearance, wrinkle depth, and skin firmness after the treatment series, each rated on a Likert scale from -5 (marked worsening) to +5 (marked improvement), with 0 indicating no change.
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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
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Satisfaction With Wrinkle-Reduction and Firming Effects
時間枠：Immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals)
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Participants' satisfaction with the wrinkle-reduction effect and with the firming effect of the treatment, each rated on a scale from 0 (not satisfied at all) to 10 (extremely satisfied).
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Immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals)
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Proportion of Participants Satisfied With Facial and Neck Appearance
時間枠：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)
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Percentage of participants reporting satisfaction with the appearance of their face and neck, assessed before treatment and after the treatment series.
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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)
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Percentage Retention of Maximal Improvement in Wrinkle Volume and Skin Texture at 12 Weeks
時間枠：2 weeks and 12 weeks after the treatment series
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Persistence of the treatment effect, calculated as the percentage of the maximal improvement (observed at 2 weeks) that was retained at 12 weeks, for wrinkle volume and skin texture/roughness parameters measured by Antera 3D.
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2 weeks and 12 weeks after the treatment series
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Incidence of Local Skin Reactions and Adverse Events
時間枠：Throughout the treatment series and follow-up period, up to 12 weeks after the last session
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Clinical monitoring for adverse events and local skin reactions associated with the procedure.
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Throughout the treatment series and follow-up period, up to 12 weeks after the last session
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Anna Deda, PhD、Medical University of Silesia in Katowice
- スタディチェア：Dominika Wcisło-Dziadecka, Prof、Medical University of Silesia in Katowice
- スタディディレクター：Sławomir Wilczyński, Prof、Medical University of Silesia in Katowice
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Chen FP, Lee N, Soong YK, Huang KE. Short- and long-term effects of hormone replacement therapy on cardiovascular risk factors in postmenopausal women. Chang Gung Med J. 2001 Jul;24(7):431-9.
- FORBES JI. Myasthenia gravis in an African woman. Cent Afr J Med. 1960 Jul;6:295-7. No abstract available.
- Houshmand EB. Effect of glycolic acid, phytic acid, soothing complex containing Emulsion on Hyperpigmentation and skin luminosity: A clinical evaluation. J Cosmet Dermatol. 2021 Mar;20(3):776-780. doi: 10.1111/jocd.13950. Epub 2021 Feb 2.
- Genever PG, Maxfield SJ, Kennovin GD, Maltman J, Bowgen CJ, Raxworthy MJ, Skerry TM. Evidence for a novel glutamate-mediated signaling pathway in keratinocytes. J Invest Dermatol. 1999 Mar;112(3):337-42. doi: 10.1046/j.1523-1747.1999.00509.x.
- Cuenod M, Do KQ, Herrling PL, Turski WA, Matute C, Streit P. Homocysteic acid, an endogenous agonist of NMDA-receptor: release, neuroactivity and localization. Adv Exp Med Biol. 1986;203:253-62. doi: 10.1007/978-1-4684-7971-3_19. No abstract available.
- Passeron T, Picardo M. Melasma, a photoaging disorder. Pigment Cell Melanoma Res. 2018 Jul;31(4):461-465. doi: 10.1111/pcmr.12684. Epub 2018 Jan 12.
- Shin JW, Kwon SH, Choi JY, Na JI, Huh CH, Choi HR, Park KC. Molecular Mechanisms of Dermal Aging and Antiaging Approaches. Int J Mol Sci. 2019 Apr 29;20(9):2126. doi: 10.3390/ijms20092126.
- Gromkowska-Kepka KJ, Puscion-Jakubik A, Markiewicz-Zukowska R, Socha K. The impact of ultraviolet radiation on skin photoaging - review of in vitro studies. J Cosmet Dermatol. 2021 Nov;20(11):3427-3431. doi: 10.1111/jocd.14033. Epub 2021 Mar 13.
- Miao F, Wan J, Zhou Y, Shi Y. Unraveling Melasma: From Epidermal Pigmentation to Microenvironmental Dysregulation. Biology (Basel). 2025 Oct 13;14(10):1402. doi: 10.3390/biology14101402.
- Lee H, Hong Y, Kim M. Structural and Functional Changes and Possible Molecular Mechanisms in Aged Skin. Int J Mol Sci. 2021 Nov 19;22(22):12489. doi: 10.3390/ijms222212489.
- Ni J, Wang N, Gao L, Li L, Zheng S, Liu Y, Ozukum M, Nikiforova A, Zhao G, Song Z. The effect of the NMDA receptor-dependent signaling pathway on cell morphology and melanosome transfer in melanocytes. J Dermatol Sci. 2016 Dec;84(3):296-304. doi: 10.1016/j.jdermsci.2016.08.534. Epub 2016 Aug 24.
- Kaltchenko MV, Chien AL. Photoaging: Current Concepts on Molecular Mechanisms, Prevention, and Treatment. Am J Clin Dermatol. 2025 May;26(3):321-344. doi: 10.1007/s40257-025-00933-z. Epub 2025 Mar 12.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月29日
一次修了 (実際)
2026年4月1日
研究の完了 (実際)
2026年4月1日
試験登録日
最初に提出
2026年7月9日
QC基準を満たした最初の提出物
2026年7月22日
最初の投稿 (実際)
2026年7月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月23日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- KNW/0022/KB1/27/16
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The individual participant data underlying the results reported in this article are included in the article and its supplementary materials.
Further inquiries can be directed to the corresponding author.
IPD 共有時間枠
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
IPD 共有アクセス基準
Data will be made available to qualified researchers who submit a reasonable request to the corresponding author (Anna Deda, adeda@sum.edu.pl), for the purpose of methodologically sound reanalysis, subject to authors' approval.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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