- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07637032
Clinical Study of a Facial Cream for Rosacea
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Yanwen Jiang
- Numero di telefono: 13501700841
- Email: jiangyanwen@china-norm.com
Luoghi di studio
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Shanghai, Cina
- Reclutamento
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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Contatto:
- Yanwen Jiang
- Numero di telefono: +86 13501700841
- Email: jiangyanwen@china-norm.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dermatologist-Assessed Rosacea Severity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in Skin Hydration Measured by Corneometer
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- C26036010
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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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