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

Last updated: February 25, 2025
Sponsor: NAOS Argentina S.A.
Overall Status: Completed

Phase

N/A

Condition

Rosacea

Scleroderma

Hot Flash

Treatment

Placebo

SCARCr tester 1

Clinical Study ID

NCT06582043
RC2024/SCARCr/AR-BR
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject with facial vascular rosacea with flushing, permanent redness,telangiectasias and at least 3 papules and/or pustules (this last criterion for atleast 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 studyproduct

  • 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 scheduledvisits

  • Subject that has signed informed consent

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman

  • Subject showing cutaneous marks on the experimental areas, which could interferewith 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 thanthe 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 usualhormonal 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 productand sunscreen

  • Subject with anti-ageing or aesthetic treatment during the last 6 months: botox orbotox like products, peelings, plastic surgery, hyaluronic acid treatment, PlasmaRich Platelets treatment, or any other specific treatments prone to change the skinaspect

  • Subject with antibiotic, anti-allergic, anti-inflammatory treatment or treatmentwith patent medicines containing Vitamin A acid or its derivatives within 4 weeksand during the study (if therapeutic requirement: exclusion foreseen),

  • 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, aunilateral mastectomy with lymph node removal within the last year, or a bilateralaxillary lymph node removal,

  • Subject with a history of immune deficiency or auto-immune disease, treated formalignancy within 6 months prior to enrolment or who are currently under treatmentfor asthma or diabetes, forecast of vaccination during the test period or lastvaccination within 3 weeks before the study.

  • Subject receiving local treatment for rosacea (cyclins, isotretinoin) or who hasundergone local active treatment for rosacea (erythromycin, metronidazole, benzoylperoxide, ivermectin) within 4 weeks before inclusion in the study

  • Subject who has had oral treatment with metronidazole or cyclins within 4 weeksbefore inclusion in the study

  • Subject who has had topical or oral anti-inflammatory and/or antiallergy treatment (corticosteroid, antihistamine, anti-inflammatory drugs, immunosuppressives) within 4 weeks before inclusion in the study

  • Subject who has had oral treatment with retinoids within 2 months before inclusionin the study

  • Subject currently receiving electrocoagulation or laser treatment for telangiectasia

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
May 16, 2024
Estimated Completion Date:
February 06, 2025

Study 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.

Connect with a study center

  • Cirec Latam

    Ciudad Autónoma de Buenos Aire, 1426
    Argentina

    Site Not Available

  • MEDCIN

    São Paulo, 01311-000
    Brazil

    Site Not Available

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