An interventional study of SCARCr tester 1 and Placebo in Rosacea, Redness and Telangiectasia, sponsored by NAOS Argentina S.A.. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by NAOS Argentina S.A. · Not applicable, Interventional, and 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.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 70 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →NAOS Argentina S.A. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Twice daily
Twice daily
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).
Time frame: Day 0- Day 28- Day 56- Day 84
Cutaneous and ocular tolerance
Collection of adverse events
Time frame: Day 0- Day 28- Day 56- Day 84
Evolution of the quality of life RosaQoL (Rosacea Quality of Life) questionnaire
Scoring scale from better to worse value: never, rarely, sometimes, often and always. Minimum value: never; Maximun value: always.
Time frame: Day 0- Day 28- Day 56- Day 84
Evolution of the quality of life Mood Pict
Scoring scale from better to worse value: not at all, lightly, moderate, a lot and extremely.
Time frame: Day 0- Day 28- Day 56- Day 84
Evolution of the quality of life Feel Pict questionnaires
Scoring scale from better to worse value; low and high.
Time frame: Day 0- Day 28- Day 56- Day 84
Evaluate the immediate and long-lasting eficacy and cosmetic qualities
Self-assessment questionnaires by the subjects (scoring scale from better to worse value: totally agree, agree, disagree and totally disagree).
Time frame: Day 0- Day 28- Day 56- Day 84
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Jan 2025, 7 months.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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NAOS Argentina S.A.