Clinical trial NCT06582043: Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea
Official title: Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects Presenting With Rosacea Treated With Topical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Redness
Telangiectasia
Flushing
Pustular Acne
Papule Pruritic
Keywords: Rosacea
Lead sponsor: NAOS Argentina S.A.
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 antibiotic, anti-allergic, anti-inflammatory treatment or treatment with patent medicines containing Vitamin A acid or its derivatives within 4 weeks and 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, 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.
* Subject receiving local treatment for rosacea (cyclins, isotretinoin) or who has undergone local active treatment for rosacea (erythromycin, metronidazole, benzoyl peroxide, ivermectin) within 4 weeks before inclusion in the study
* Subject who has had oral treatment with metronidazole or cyclins within 4 weeks before 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 inclusion in the study
* Subject currently receiving electrocoagulation or laser treatment for telangiectasia

Primary outcomes:
measure: Investigator Global Assessment (IGA)
timeFrame: Day 0- Day 28- Day 56- Day 84
Secondary outcomes:
measure: Cutaneous and ocular tolerance
timeFrame: Day 0- Day 28- Day 56- Day 84
Other outcomes:
measure: Evolution of the quality of life RosaQoL (Rosacea Quality of Life) questionnaire
timeFrame: Day 0- Day 28- Day 56- Day 84
measure: Evolution of the quality of life Mood Pict
timeFrame: Day 0- Day 28- Day 56- Day 84
measure: Evolution of the quality of life Feel Pict questionnaires
timeFrame: Day 0- Day 28- Day 56- Day 84
measure: Evaluate the immediate and long-lasting eficacy and cosmetic qualities
timeFrame: Day 0- Day 28- Day 56- Day 84
Locations:
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Cirec Latam
city: São Paulo
country: Brazil
facility: MEDCIN
Study officials:
References: