Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582043
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects Presenting With Rosacea Treated With Topical Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil Under dermatological and ophthalmological control 4 visits inclusion DayD0 D28 D56 D84 Ethical committee required
Detailed Description:
Primary objective
To evaluate the efficacy of two cosmetic products SCARCr tester 1 and SCARCr tester 2 in association to the topical medical treatment Ivermectin or Metronidazole in supporting the improvement of persistent redness due to rosacea and in soothing discomfort sensations under dermatological and ophthalmological control
Secondary objectives
To evaluate the cutaneous and ocular tolerance of two cosmetic products in subjects presenting with rosacea under treatment with topical Ivermectin or Metronidazole for 56 days and 28 days after applying the cosmetic products alone To evaluate the efficacyof two cosmetic products through clinical evaluation of the symptoms related to rosacea after 56 days of concomitant use of the cosmetic product with the topical medical treatment and 28 days after applying the cosmetic products alone To evaluate the efficacyof two cosmetic products through instrumental measurements of redness after 56 days of concomitant use of the cosmetic product with the topical medical treatment and 28 days after applying the cosmetic products alone To evaluate the evolution of the quality of life of the subjects over the period of use of the association of the topical medical treatment with the cosmetic products 56 days and 28 days after applying the cosmetic products alone To evaluate the immediate and long-lasting eCicacy and cosmetic qualities of the cosmetic products based on self-assessment questionnaires by the subjects To compare the two products tolerance and efficacy
To evaluate the efficacy of two cosmetic products SCARCr tester 1 and SCARCr tester 2 in association to the topical medical treatment Ivermectin or Metronidazole in supporting the improvement of persistent redness due to rosacea and in soothing discomfort sensations under dermatological and ophthalmological control
Secondary objectives
To evaluate the cutaneous and ocular tolerance of two cosmetic products in subjects presenting with rosacea under treatment with topical Ivermectin or Metronidazole for 56 days and 28 days after applying the cosmetic products alone To evaluate the efficacyof two cosmetic products through clinical evaluation of the symptoms related to rosacea after 56 days of concomitant use of the cosmetic product with the topical medical treatment and 28 days after applying the cosmetic products alone To evaluate the efficacyof two cosmetic products through instrumental measurements of redness after 56 days of concomitant use of the cosmetic product with the topical medical treatment and 28 days after applying the cosmetic products alone To evaluate the evolution of the quality of life of the subjects over the period of use of the association of the topical medical treatment with the cosmetic products 56 days and 28 days after applying the cosmetic products alone To evaluate the immediate and long-lasting eCicacy and cosmetic qualities of the cosmetic products based on self-assessment questionnaires by the subjects To compare the two products tolerance and efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None