Homocysteic Acid Biostimulator for Photoaged Facial Skin
22 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Sosnowiec, Polonia
- Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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+).
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of Local Skin Reactions and Adverse Events
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Anna Deda, PhD, Medical University of Silesia in Katowice
- Cattedra di studio: Dominika Wcisło-Dziadecka, Prof, Medical University of Silesia in Katowice
- Direttore dello studio: Sławomir Wilczyński, Prof, Medical University of Silesia in Katowice
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
29 ottobre 2025
Completamento primario (Effettivo)
1 aprile 2026
Completamento dello studio (Effettivo)
1 aprile 2026
Date di iscrizione allo studio
Primo inviato
9 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 luglio 2026
Primo Inserito (Effettivo)
23 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KNW/0022/KB1/27/16
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano 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.
Periodo di condivisione IPD
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .