- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07561242
Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses
24 kwietnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
20
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yanwen Jiang
- Numer telefonu: 13501700841
- E-mail: jiangyanwen@china-norm.com
Lokalizacje studiów
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200072
- Rekrutacyjny
- Shanghai China-norm Quality Technical Service Co., Ltd.
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Kontakt:
- Wenqu Tang
- Numer telefonu: 13585634612
- E-mail: tangwenqu@china-norm.com
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Change in Composite Clinical Skin Damage Score as Assessed by Clinician
Ramy czasowe: 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.
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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.
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Change in Skin Color Parameters (L, a, b*, ITA°) measured by Chromameter CM26dG
Ramy czasowe: 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.
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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.
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|
Change in Melanin and Hemoglobin Index measured by Mexameter MX18
Ramy czasowe: 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.
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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.
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Change in Transepidermal Water Loss (TEWL) measured by Vapometer
Ramy czasowe: 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.
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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.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
21 marca 2026
Zakończenie podstawowe (Szacowany)
30 kwietnia 2026
Ukończenie studiów (Szacowany)
30 kwietnia 2026
Daty rejestracji na studia
Pierwszy przesłany
13 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
1 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- R26000004
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .