- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07637032
Clinical Study of a Facial Cream for Rosacea
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yanwen Jiang
- Numer telefonu: 13501700841
- E-mail: jiangyanwen@china-norm.com
Lokalizacje studiów
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Shanghai, Chiny
- Rekrutacyjny
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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Kontakt:
- Yanwen Jiang
- Numer telefonu: +86 13501700841
- E-mail: jiangyanwen@china-norm.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Female Chinese subjects aged 20 to 50 years with Fitzpatrick skin type III-IV;
- In good general health, with no chronic diseases or illnesses under treatment;
- Assessed by a dermatologist at the baseline visit:
(1)Present with persistent mild erythema on the midface (cheeks, nose, chin and forehead), graded as mild to moderate with a score of 2-3 according to the Clinician's Erythema Assessment (CEA, 0-4 scale) for facial persistent erythema; (2)Graded as mild to moderate with a score of 2-3 based on the papule and pustule assessment scale, inflammatory lesion count and Investigator's Global Assessment (IGA, 0-4 scale); (3)5Have no more than 3 mild inflammatory papules/pustules on the face; Present with none or only very mild facial telangiectasia; (4)Have not changed daily skin care products in the past three months, and do not use soothing skin care products, medical devices or medical dressings. 4.No additional or replacement skin care products are permitted throughout the study period except the test product.
5.The participants voluntarily join the study, fully understand the trial content and are willing to sign the informed consent form and portrait use authorization.
6.During the entire study period, participants shall comply with the study protocol, use the products provided by the study, and refrain from using other similar products. They are also required to keep study diaries and attend regular follow-up visits as stipulated.
Exclusion Criteria:
- Female participants who are planning to become pregnant, are pregnant or breastfeeding, are within 6 months post-delivery, or refuse to take adequate contraceptive precautions.
- Participants currently enrolled in another clinical trial, or who have participated in any other clinical trial within the preceding 3 months.
- Participants who have received physical, chemical or cosmetic procedures within 3 months prior to study enrollment.
- Participants who have used any medications for rosacea within 4 weeks prior to enrollment, including topical preparations (metronidazole, azelaic acid, erythromycin ointment, etc.), oral agents (minocycline, doxycycline, oral isotretinoin, etc.) or corticosteroids (e.g., hydrocortisone).
- Participants with systemic diseases complicated by severe organ damage, cardiovascular diseases, hepatic or renal dysfunction, malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgery or trauma, psychiatric disorders; or those requiring topical or systemic medications/treatments that may affect atopic dermatitis for other medical conditions.
- Participants with other dermatoses (atopic dermatitis, seborrheic dermatitis, eczema, etc.) or evaluative confounding skin conditions (birthmarks, scars, etc.) at the study site.
- Participants presenting with symptoms of phymatous rosacea or ocular rosacea at the study site.
- Participants with a history of allergic contact dermatitis induced by cleansers or moisturizers.
- Participants with a history of allergy to the investigational product or its ingredients, or a history of severe allergic reactions.
- Participants who fail to meet compliance requirements, are unable to attend scheduled visits on time, or are unwilling to abide by the study protocol throughout the trial.
- Any other conditions that, in the investigator's opinion, make the individual unsuitable for study participation.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Arm 1
Investigational test cream, designed to evaluate its soothing effect on skin.
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Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the investigational product cream (1-2 pumps per use) to the entire face and gently massage until absorbed.
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Eksperymentalny: Arm 2
Subjects' own non-soothing daily facial cream, used as a negative control.
No study-specific active intervention is provided in this arm.
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Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the participants' usual non-soothing facial cream (per their regular daily usage) to the entire face and gently massage until absorbed.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dermatologist-Assessed Rosacea Severity
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Investigator's Global Assessment (IGA) is a clinical tool that can be used to evaluate the severity of rosacea.
The severity of rosacea is assessed and determined using the IGA grading scale, with scores recorded at T0 (baseline), T2w (2 weeks), T4w (4 weeks), and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of persistent erythema
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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The Persistent Erythema CEA Scale (0-4 points) is used to assess persistent erythema.
Scoring will be performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of Counting Inflammatory Lesions
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Assessment of subjects' telangiectasia is conducted using the TRoSA Telangiectasia Scale (0-4 points).
Scoring is performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of product tolerability
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologists use the safety assessment scale (0-3 points) to evaluate symptoms including edema, papules, desquamation, stinging, pruritus and burning.
Assessments are performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Self-assessment Questionnaire
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Study participants are required to complete the skin sensation self-assessment questionnaire (Likert scale) and the Dermatology Life Quality Index (DLQI) at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Change in Skin Hydration Measured by Corneometer
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Transepidermal Water Loss (TEWL) measured by Tewameter® TM HEX (Courage + Khazaka, Germany)
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Hemoglobin Index measured by Mexameter® MX 18 (Courage + Khazaka, Germany)
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Skin changes captured via VISIA-CR imaging (Canfield Scientific, Inc., USA)
Ramy czasowe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- C26036010
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .
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