NCT06582043

Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea

Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects Presenting With Rosacea Treated With Topical Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: NAOS Argentina S.A. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control 4 visits: inclusion \[Day(D)0\], 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.

Conditions

• Rosacea
• Redness
• Telangiectasia
• Flushing
• Pustular Acne
• Papule Pruritic

Interventions

Type	Name	Description
OTHER	SCARCr tester 1	Twice daily
OTHER	Placebo	Twice daily

Timeline

• Start date: 2024-05-16
• Primary completion: 2025-01-09
• Completion: 2025-02-06
• First posted: 2024-09-03
• Last updated: 2025-02-28

Locations

2 sites across 2 countries: Argentina, Brazil