Homocysteic Acid Biostimulator for Photoaged Facial Skin
22. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
25
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Sosnowiec, Polen
- Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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+).
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
Zeitfenster: 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.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Wrinkle Volume (Antera 3D)
Zeitfenster: 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.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Skin Texture Score (Antera 3D)
Zeitfenster: 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.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Skin Roughness (Antera 3D, Ra)
Zeitfenster: Baseline, 2 weeks, and 12 weeks after the treatment series
|
Arithmetic roughness (Ra), measured in micrometres (µm) by Antera 3D.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Maximum Wrinkle Height (Antera 3D)
Zeitfenster: Baseline, 2 weeks, and 12 weeks after the treatment series
|
Maximum surface height of wrinkles, measured in millimetres (mm) by Antera 3D.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Skin Hydration
Zeitfenster: Baseline, 2 weeks, and 12 weeks after the treatment series
|
Skin hydration measured by corneometry (arbitrary corneometer units).
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Sebum Secretion
Zeitfenster: Baseline, 2 weeks, and 12 weeks after the treatment series
|
Sebum secretion measured by sebumetry.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Skin Tone Contrast (GLCM) in Participants With Hyperpigmentation
Zeitfenster: 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.
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
|
Change From Baseline in Skin Tone Homogeneity (GLCM) in Participants With Hyperpigmentation
Zeitfenster: 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).
|
Baseline, 2 weeks, and 12 weeks after the treatment series
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness
Zeitfenster: 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
|
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.
|
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
Zeitfenster: Immediately after the fourth treatment session (each session is a single-day clinic visit; the four sessions were administered at 14-day intervals)
|
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).
|
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
Zeitfenster: 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 of participants reporting satisfaction with the appearance of their face and neck, assessed before treatment and after the treatment series.
|
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
Zeitfenster: 2 weeks and 12 weeks after the treatment series
|
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.
|
2 weeks and 12 weeks after the treatment series
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Local Skin Reactions and Adverse Events
Zeitfenster: Throughout the treatment series and follow-up period, up to 12 weeks after the last session
|
Clinical monitoring for adverse events and local skin reactions associated with the procedure.
|
Throughout the treatment series and follow-up period, up to 12 weeks after the last session
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Anna Deda, PhD, Medical University of Silesia in Katowice
- Studienstuhl: Dominika Wcisło-Dziadecka, Prof, Medical University of Silesia in Katowice
- Studienleiter: Sławomir Wilczyński, Prof, Medical University of Silesia in Katowice
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
29. Oktober 2025
Primärer Abschluss (Tatsächlich)
1. April 2026
Studienabschluss (Tatsächlich)
1. April 2026
Studienanmeldedaten
Zuerst eingereicht
9. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juli 2026
Zuerst gepostet (Tatsächlich)
23. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KNW/0022/KB1/27/16
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .