Homocysteic Acid Biostimulator for Photoaged Facial Skin
22 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
25
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Sosnowiec, Polska
- Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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+).
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence of Local Skin Reactions and Adverse Events
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Anna Deda, PhD, Medical University of Silesia in Katowice
- Krzesło do nauki: Dominika Wcisło-Dziadecka, Prof, Medical University of Silesia in Katowice
- Dyrektor Studium: Sławomir Wilczyński, Prof, Medical University of Silesia in Katowice
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
29 października 2025
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2026
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2026
Daty rejestracji na studia
Pierwszy przesłany
9 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 lipca 2026
Pierwszy wysłany (Rzeczywisty)
23 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KNW/0022/KB1/27/16
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .