NCT07722351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 9, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

chemical skin biostimulatorphotoaginghomocysteic acidammonium trichloroacetateskin elasticitywrinkle reductionmelasmaCutometerAntera 3Dgrey-level co-occurrence matrix

Outcome Measures

Primary Outcomes (9)

  • Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)

    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)

    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)

    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)

    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)

    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

    Skin hydration measured by corneometry (arbitrary corneometer units).

    Baseline, 2 weeks, and 12 weeks after the treatment series

  • Change From Baseline in Sebum Secretion

    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

    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

    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

Secondary Outcomes (4)

  • 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

Other Outcomes (1)

  • Incidence of Local Skin Reactions and Adverse Events

    Throughout the treatment series and follow-up period, up to 12 weeks after the last session

Study Arms (1)

Chemical skin biostimulator (ATCA/HoA) plus home-care regimen

EXPERIMENTAL

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.

Procedure: Chemical skin biostimulation with ammonium trichloroacetate and homocysteic acid

Interventions

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+).

Also known as: PRX plus
Chemical skin biostimulator (ATCA/HoA) plus home-care regimen

Eligibility Criteria

Age39 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, Fitzpatrick skin phototype II
  • Age 39-69 years
  • Clinical signs of facial photoaging
  • Some participants had hyperpigmentation (melasma or post-inflammatory hyperpigmentation)

You may not qualify if:

  • Pregnancy or breastfeeding
  • Ongoing hormone therapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice

Sosnowiec, Poland

Location

Related Publications (12)

  • 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.

    PMID: 11565249BACKGROUND
  • FORBES JI. Myasthenia gravis in an African woman. Cent Afr J Med. 1960 Jul;6:295-7. No abstract available.

    PMID: 13823881BACKGROUND
  • 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.

    PMID: 33458927BACKGROUND
  • 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.

    PMID: 10084312BACKGROUND
  • 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.

    PMID: 2878563BACKGROUND
  • 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.

    PMID: 29285880BACKGROUND
  • 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.

    PMID: 31036793BACKGROUND
  • 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.

    PMID: 33655657BACKGROUND
  • 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.

    PMID: 41154805BACKGROUND
  • 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.

    PMID: 34830368BACKGROUND
  • 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.

    PMID: 27596138BACKGROUND
  • 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.

    PMID: 40072791BACKGROUND

MeSH Terms

Conditions

HyperpigmentationMelanosis

Interventions

homocysteic acid

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anna Deda, PhD

    Medical University of Silesia in Katowice

    PRINCIPAL INVESTIGATOR
  • Dominika Wcisło-Dziadecka, Prof

    Medical University of Silesia in Katowice

    STUDY CHAIR
  • Sławomir Wilczyński, Prof

    Medical University of Silesia in Katowice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 23, 2026

Study Start

October 29, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
Access Criteria
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.

Locations