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Completed

NCT Number: NCT07722351

Homocysteic Acid Biostimulator for Photoaged Facial 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.

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Key information

Conditions

Skin Aging Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

39 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Sosnowiec, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemical skin biostimulation with ammonium trichloroacetate and homocysteic acid

Procedure

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+).

Other names: PRX plus

Primary outcomes

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

    Time frame: 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.

  2. Change From Baseline in Wrinkle Volume (Antera 3D)

    Time frame: 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.

  3. Change From Baseline in Skin Texture Score (Antera 3D)

    Time frame: 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.

  4. Change From Baseline in Skin Roughness (Antera 3D, Ra)

    Time frame: Baseline, 2 weeks, and 12 weeks after the treatment series

    Arithmetic roughness (Ra), measured in micrometres (µm) by Antera 3D.

  5. Change From Baseline in Maximum Wrinkle Height (Antera 3D)

    Time frame: Baseline, 2 weeks, and 12 weeks after the treatment series

    Maximum surface height of wrinkles, measured in millimetres (mm) by Antera 3D.

  6. Change From Baseline in Skin Hydration

    Time frame: Baseline, 2 weeks, and 12 weeks after the treatment series

    Skin hydration measured by corneometry (arbitrary corneometer units).

  7. Change From Baseline in Sebum Secretion

    Time frame: Baseline, 2 weeks, and 12 weeks after the treatment series

    Sebum secretion measured by sebumetry.

  8. Change From Baseline in Skin Tone Contrast (GLCM) in Participants With Hyperpigmentation

    Time frame: 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.

  9. Change From Baseline in Skin Tone Homogeneity (GLCM) in Participants With Hyperpigmentation

    Time frame: 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).

Secondary outcomes

  1. Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness

    Time frame: 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.

  2. Satisfaction With Wrinkle-Reduction and Firming Effects

    Time frame: 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).

  3. Proportion of Participants Satisfied With Facial and Neck Appearance

    Time frame: 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.

  4. Percentage Retention of Maximal Improvement in Wrinkle Volume and Skin Texture at 12 Weeks

    Time frame: 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.

Other outcomes

  1. Incidence of Local Skin Reactions and Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • WiQO (Trieste, Italy)

Registry information

Official study title

Instrumental Assessment of a Homocysteic Acid-containing Chemical Skin Biostimulator in the Management of Photoaged Mature Skin

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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