- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07637032
Clinical Study of a Facial Cream for Rosacea
Studie Overzicht
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Yanwen Jiang
- Telefoonnummer: 13501700841
- E-mail: jiangyanwen@china-norm.com
Studie Locaties
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Shanghai, China
- Werving
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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Contact:
- Yanwen Jiang
- Telefoonnummer: +86 13501700841
- E-mail: jiangyanwen@china-norm.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dermatologist-Assessed Rosacea Severity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in Skin Hydration Measured by Corneometer
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- C26036010
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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