Homocysteic Acid Biostimulator for Photoaged Facial Skin
2026년 7월 22일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
25
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sosnowiec, 폴란드
- Department of Practical Cosmetology and Skin Diagnostics, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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+).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Skin Viscoelasticity (Cutometer R2, R5, R7)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Self-Assessed Facial Appearance, Neck Appearance, Wrinkle Depth, and Skin Firmness
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Local Skin Reactions and Adverse Events
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Anna Deda, PhD, Medical University of Silesia in Katowice
- 연구 의자: Dominika Wcisło-Dziadecka, Prof, Medical University of Silesia in Katowice
- 연구 책임자: Sławomir Wilczyński, Prof, Medical University of Silesia in Katowice
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 10월 29일
기본 완료 (실제)
2026년 4월 1일
연구 완료 (실제)
2026년 4월 1일
연구 등록 날짜
최초 제출
2026년 7월 9일
QC 기준을 충족하는 최초 제출
2026년 7월 22일
처음 게시됨 (실제)
2026년 7월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 22일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- KNW/0022/KB1/27/16
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .