RosaceaNCT06582043
Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects With Rosacea
A study testing SCARCr tester 1 in people with Rosacea and Redness, run by NAOS Argentina S.A. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Redness, Telangiectasia
- What is being tested?
- SCARCr tester 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 May 2024to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects Presenting With Rosacea Treated With Topical Treatment
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.
Read the 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
- Being tested
- SCARCr tester 1, Placebo
- Keywords
- Rosacea
- Medical subject headings
- Rosacea, Erythema, Telangiectasis, Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCARCr tester 1Other
Twice daily
PlaceboOther
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: SCARCr tester 1; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0- Day 28- Day 56- Day 84
Secondary outcomes (1)
Cutaneous and ocular tolerance
Collection of adverse events
Measured: Day 0- Day 28- Day 56- Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 May 2024
- Primary completion9 Jan 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- NAOS Argentina S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582043
- Sponsor's protocol ID
- RC2024/SCARCr/AR-BR
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of Two Cosmetic Products in Subjects Presenting With Rosacea Treated With Topical Treatment
- ClinicalTrials.gov ID
- NCT06582043
- Acronym / sponsor ID
- RC2024/SCARCr/AR-BR
- Conditions
- Rosacea, Redness, Telangiectasia, Flushing, Pustular Acne, Papule Pruritic
- Keywords
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NAOS Argentina S.A.Industry (pharma, biotech, devices)
- Study start
- 16 May 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicentric and double-blind randomised comparative clinical study in Argentina and Brazil. Under dermatological and ophthalmological control
| Arm | Type | Receives |
|---|---|---|
| SCARCr tester 1 | Active comparator | Other: SCARCr tester 1, Other: PlaceboThe 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 |
| SCARCr tester 2 | Placebo comparator | Other: SCARCr tester 1, Other: PlaceboThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCARCr tester 1Twice daily | Other | SCARCr tester 1, SCARCr tester 2 |
| PlaceboTwice daily | Other | SCARCr tester 1, SCARCr tester 2 |
Primary outcome
Investigator Global Assessment (IGA)
Time frame: Day 0- Day 28- Day 56- Day 84
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).
1 secondary outcome
Cutaneous and ocular tolerance
Time frame: Day 0- Day 28- Day 56- Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCARCr tester 1 in people with Rosacea and Redness, run by NAOS Argentina S.A. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) (time frame: Day 0- Day 28- Day 56- Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.