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Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses

24 aprile 2026 aggiornato da: ChinaNorm
This clinical observational study investigates the dose-response relationship between laser energy intensity and skin damage/repair by applying different parameter sets of fractional ablative (CO2) and non-ablative (M22) lasers to the inner forearms of approximately 20 healthy Chinese female volunteers (aged 18-60, Fitzpatrick skin types III-V) in a single-center, self-controlled design. Each participant receives both laser types on contralateral arms, with four distinct energy/density combinations per laser applied to separate test areas, and the dynamic skin responses are evaluated at baseline, immediately post-treatment, and at 30 minutes, 1, 2, 3, 4 hours, 7 days, and 10 days thereafter through clinical assessments (edema, erythema, etc.), standardized photography, high-frequency ultrasound (Dermascan), and objective instrumental measurements of skin color (Chromameter CM26dG), melanin/hemoglobin (Mexameter MX18), and barrier function (TEWL via Vapometer). The collected data will be analyzed using descriptive and comparative statistical methods to characterize the acute injury and recovery profiles, aiming to establish a foundational model for future post-procedure cosmetic intervention research.

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Stimato)

20

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200072
        • Reclutamento
        • Shanghai China-norm Quality Technical Service Co., Ltd.
        • Contatto:

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

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Approximately 20 healthy Chinese female volunteers, aged 18-60 years with Fitzpatrick skin phototypes III, IV, or V. This population will serve as participants in a self-controlled, observational study to model laser-induced skin injury. Each participant will receive both ablative (CO2) and non-ablative (M22) fractional laser exposures with varying parameters on their inner forearms to observe the dynamic physiological response and recovery process.

Descrizione

Inclusion Criteria:

  • Female Chinese study participants aged 18 to 60 years (inclusive).
  • Fitzpatrick skin phototypes III, IV, or V.
  • Willing to receive non-ablative fractional laser (M22) and ablative fractional laser (CO2) irradiation on the test sites during the study.
  • No primary or secondary lesions (such as scars, ulcers, vesicles, tattoos) on the test sites.
  • Has not participated in any other studies involving the test area (forearms) in the past 2 months.
  • Agrees not to use skin-whitening products on the test area during the study period.
  • In good general health at the time of the study.
  • Volunteers to participate and signs the informed consent form and photo release authorization.
  • Willing to comply with all requirements of the study.

Exclusion Criteria:

  • Study participants with skin diseases or skin allergies in the test area.
  • Presence of moderate to severe inflammatory skin diseases (e.g., active eczema, acute photosensitive dermatitis, etc.) on the test sites within the past 4 weeks, or those who require treatment with oral or topical corticosteroids or immunosuppressants for skin conditions.
  • On the day of the visit, the investigator judges the presence of significant diffuse erythema, desquamation, or exudation in the test area that may significantly affect skin color measurement.
  • The investigator assesses that the participant is currently suffering from a stable or progressively worsening disease.
  • Participant is planning for pregnancy, is pregnant, or is breastfeeding (applicable to female participants only).
  • Participant with immunodeficiency.
  • Participant has a history of photosensitivity or photoallergy.
  • Participant has a history of skin cancer or malignant melanoma.
  • Presence of significant scars, tattoos, surgical incisions, or pigmented lesions (e.g., prominent birthmarks) in the test area that may affect assessment, and in the investigator's judgment, would impede normal imaging or scoring.
  • Has used high-potency active products containing high concentrations of retinoic acid/retinol, alpha hydroxy acids, salicylic acid, etc., on the test area frequently (≥3 times per week) for an extended period (≥4 weeks) within the past 3 months, which, in the investigator's judgment, may significantly affect skin texture or barrier status.
  • History of moderate to severe sun exposure (e.g., prolonged outdoor work, travel to seaside/high altitude) within the past 4 weeks, resulting in significant tanning or sunburn in the test area that, in the investigator's judgment, may interfere with study-related readings.
  • Participation in other clinical or consumer testing projects involving the skin condition of the test area within the past 4 weeks.
  • Presence of significant mental or cognitive impairment affecting compliance, and the investigator considers the participant unable to understand the study procedures or complete the tests as required.

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Change in Composite Clinical Skin Damage Score as Assessed by Clinician
Lasso di tempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Change in Skin Color Parameters (L, a, b*, ITA°) measured by Chromameter CM26dG
Lasso di tempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
Change in Melanin and Hemoglobin Index measured by Mexameter MX18
Lasso di tempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
Change in Transepidermal Water Loss (TEWL) measured by Vapometer
Lasso di tempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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)

21 marzo 2026

Completamento primario (Stimato)

30 aprile 2026

Completamento dello studio (Stimato)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

13 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • R26000004

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 .

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