Trial Radar IA | ||
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Lo studio clinico NCT07492277 (RICHER) per Lateral Canthal Lines (LCL), Perioral Rhytids è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines (RICHER) 70 Dati real-world
A Non-Interventional, Post-Market-Clinical-Follow up (PMCF), Prospective, Open-Label, Single-Center Observational Study Evaluating Croma Revitalis in Correction of Fine Lines
- RICHER
- CPH-80501
Fine lines
Crow's feet
Smile lines
Perioral rhytides
Lateral canthal lines
Dermal filler
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Responder status at Week 8 after initial treatment. | Visible aesthetic changes at Week 8 after initial treatment in the treated fine lines of at least one treatment area (LCL and/or PR), compared to baseline, as assessed by the physician using the Global Aesthetic Improvement Scale (GAIS). The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement. | 8 weeks after initial treatment |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Physician Assessment | Visible aesthetic changes at Weeks 3, 6, 12, and 24 after initial treatment compared to baseline, as assessed by the physician using the Global Aesthetic Improvement Scale (GAIS).
The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement. Responders are defined as participants with a GAIS score of 1 (very much improved) or 2 (much improved). | Weeks 3, 6, 12, and 24 after initial treatment |
Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Independent Evaluator Panel | Visible aesthetic changes at Weeks 3, 6, 12, and 24 after initial treatment compared to baseline, as assessed by an independent evaluating panel using the Global Aesthetic Improvement Scale (GAIS).
The GAIS is a 5-point scale ranging from 1 (very much improved) to 5 (worse), where lower scores indicate greater aesthetic improvement. Responders are defined as participants with a GAIS score of 1 (very much improved) or 2 (much improved). | Weeks 3, 6, 12, and 24 after initial treatment |
Change in Skin Hydration from Baseline Measured by Corneometer | Change in skin hydration compared to baseline measured using a Corneometer device, which quantifies skin hydration on the treated area(s). Higher values indicate greater skin hydration. | Week 3, 6, 8, 12, and 24 |
Change in Skin Tone from Baseline Measured by Cutometer | Change in skin tone compared to baseline measured on the treated area(s) using the Cutometer device. | Week 3, 6, 8, 12, and 24 |
Change in Skin Elasticity from Baseline Measured by Cutometer | Change in skin elasticity compared to baseline measured using a Cutometer device, which assesses the mechanical properties of the skin through suction-based deformation parameters.
Higher values indicate improved skin elasticity. | Week 3, 6, 8, 12, and 24 |
Participant Satisfaction with Treatment | Participant-reported satisfaction with treatment at each specified visit using a 5-point scale: "Very unsatisfied," "Unsatisfied," "Neither unsatisfied nor satisfied," "Satisfied," or "Very satisfied." | Week 8, 12, and 24 |
Aesthetic change based on the physician's live assessment | A live-assessment of the treated areas will be performed and the treated areas will be compared to the participant's photographs obtained at the baseline visit. The presence of the aesthetic change will be recorded as either "Yes" or "No". | Week 8, 12 an 24 |
- Participants deemed by the treating physician to have LCL and/or PR of sufficient severity to merit treatment with croma revitalis to be corrected and treatment decision is reached independent of this study.
- Male or female, 18 years of age or older at Visit 1 (Day 0).
- Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation, based on the physician's judgment.
- Participants who, according to routine clinical advice, are willing to refrain from undergoing any aesthetic or surgical procedures in the treatment area during the observation period.
- Participants who understand the purpose and nature of the observational data documentation and willingness to participate in the routine follow-up after 3, 5, 8, 12, and 24 weeks as judged by the treating physician.
- Written signed and dated informed consent.
Participants who tend to develop hypertrophic scars, have pigment disorders, or have susceptibility to keloid formation.
Participants with a history of autoimmune disease or who are receiving therapy for modification of immune response, e.g., biologics, systemic corticosteroids, cytostatic drugs (from Visit 1 \[Day 0\] until the end of the study).
Participants who are known to be hypersensitive to components of the device as HA, glycerol, or gram-positive bacterial proteins.
Participants who are pregnant or breast feeding.
Participants who are anticoagulated or with history of bleeding disorder.
Participants receiving daily treatment with platelet aggregation inhibitors (e.g., acetylsalicylic acid) unless previously cleared by their primary care physician.
Participants who have cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes) present at Visit 1 (Day 0), recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated.
Previous permanent implant or treatment with non-HA or non-collagen filler or non-absorbable sutures in the treatment area(s) any time prior to or planned during the observation period.
Participants who have received dermabrasion, mesotherapy, chemical peeling, or micro-needling within 3 months prior first treatment and planned during the observation period.
Participant has received any of the following (aesthetic) treatments in the treatment area within the last 12 months prior to the first routine treatment or planned during the observation period:
- Energy based device treatments that target collagen remodeling and/or production of collagen (e.g. laser therapy).
- Absorbable sutures (threads).
- HA or collagen dermal fillers.
- Botulinum toxin treatment.
- Facial lipolysis, including submental fat treatments.
- Facial plastic surgery.
- Bariatric surgery.
Participants with uncontrolled (or unstable) systemic diseases as per the treating physician's discretion.
Prior surgery, scars, or tattoos in the treatment area(s), that could interfere with clinical evaluation. Participants planning such procedures during the observation period will not be included.
Beard, or facial hair that could interfere in evaluation of treatment as judged by the physician.
Participants who have had or are planning to undergo bariatric surgery or facial plastic surgery in the area to be treated within less than 12 months before the first treatment in and planned during the observation period.
Planned dental/oral surgery or modification (bridge-work, implants) within 4 weeks before the first treatment in and planned during the observation period.
Current participation in another clinical study, or treatment with any investigational drug/MD/device within 30 days prior to the first treatment.
Any medical condition or treatment potentially interfering with the clinical evaluation, according to the judgment of the treating physician.
Participants whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (MPG) (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers, and other members of the armed forces, civil servants).
Croma-Pharma GmbH