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

NCT06582043 | Completed DMC

• 1 other identifier: RC2024/SCARCr/AR-BR
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

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

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment (IGA)

  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 (scoring scale from better to worse value: clear, minimal, mild and mild to moderate).

  Day 0- Day 28- Day 56- Day 84

Secondary Outcomes (1)

• Cutaneous and ocular tolerance

  Day 0- Day 28- Day 56- Day 84

Other Outcomes (4)

• Evolution of the quality of life RosaQoL (Rosacea Quality of Life) questionnaire

  Day 0- Day 28- Day 56- Day 84

• Evolution of the quality of life Mood Pict

  Day 0- Day 28- Day 56- Day 84

• Evolution of the quality of life Feel Pict questionnaires

  Day 0- Day 28- Day 56- Day 84

Study Arms (2)

SCARCr tester 1

ACTIVE COMPARATOR

The subjects will apply the product concomitantly with the topical medical treatment for 56 days, followed by 28 days applying the SCARCr tester 1 alone. Instructions for topical medical treatment and study product application: 1. Application of the topical treatment (metronidazole twice daily, morning and night, or ivermectin daily at night) 2. After 5 minutes, application of the study product starting on the eye area followed by the whole face and neck, twice a day, morning and evening. Subjects must keep their usual habits during the clinical study (hygiene products, sunscreen, make-up). If the application of sunscreen

Other: SCARCr tester 1; Other: Placebo

SCARCr tester 2

PLACEBO COMPARATOR

The subjects will apply the product concomitantly with the topical medical treatment for 56 days, followed by 28 days applying the SCARCr tester 2 alone. Instructions for topical medical treatment and study product application: 1. Application of the topical treatment (metronidazole twice daily, morning and night, or ivermectin daily at night) 2. After 5 minutes, application of the study product starting on the eye area followed by the whole face and neck, twice a day, morning and evening. Subjects must keep their usual habits during the clinical study (hygiene products, sunscreen, make-up). If the application of sunscreen

Other: SCARCr tester 1; Other: Placebo

Interventions

SCARCr tester 1 OTHER

Twice daily

SCARCr tester 1; SCARCr tester 2

Placebo OTHER

Twice daily

SCARCr tester 1; SCARCr tester 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with facial vascular rosacea with flushing, permanent redness, telangiectasias and at least 3 papules and/or pustules (this last criterion for at least 10 subjects per group)
• Subject starting local treatment for rosacea (Ivermectin or metronidazole)
• Female aged 18 to 65 years old,
• Subject of all types of skin
• Subject of I to IV phototype.
• Subject accepting not to use any type of facial skin care other than the study product
• Subject willing to keep their usual habits and products (hygiene products, sunscreen, and make-up, if applicable)
• Subject willing to avoid sun exposure during the study period
• Subject willing to actively participate in the study and to come to the scheduled visits
• Subject that has signed informed consent

You may not qualify if:

• Pregnant or breastfeeding woman
• Subject showing cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn)
• Subject with documented allergy or reactivity to products of the same category than the tested one
• Subject with documented allergies to study product components
• Subject with history of malignant melanomas (Dubreuilh melanosis…)
• Subject with unbalanced hormonal treatment
• Subject with forecast of initiation of a hormonal treatment or change of the usual hormonal treatment during the study period
• Subject with forecast of sun or UVA exposure (UV lamps) during the study period
• Subject not willing to use sun protective clothes orhat if exposed to the sun
• Subject not willing to respect the methods of use of the treatment, study product and sunscreen
• Subject with anti-ageing or aesthetic treatment during the last 6 months: botox or botox like products, peelings, plastic surgery, hyaluronic acid treatment, Plasma Rich Platelets treatment, or any other specific treatments prone to change the skin aspect
• Subject with systemic disorder: cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
• Subject presenting chronic diseases with impact on skin
• Subject who has undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
• Subject with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrolment or who are currently under treatment for asthma or diabetes, forecast of vaccination during the test period or last vaccination within 3 weeks before the study.

Sponsors & Collaborators

• NAOS Argentina S.A.: lead

Study Sites (2)

Cirec Latam

Ciudad Autónoma de Buenos Aire, 1426, Argentina

Location

MEDCIN

São Paulo, 01311-000, Brazil

Location

MeSH Terms

Conditions

Rosacea; Erythema; Telangiectasis; Flushing

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization for product allocation will consider: number of papules/pustules (\<3, ≥3), age (18-35, 35-50, \>51), phototype (I-III and IV), sun protector (always, sometimes, never)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 3, 2024
• Study Start: May 16, 2024
• Primary Completion: January 9, 2025
• Study Completion: February 6, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); AR (1)