A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines (RICHER)

Croma-Pharma

Status: Enrolling

Conditions: Perioral Rhytids; Lateral Canthal Lines (LCL)

Study type: Observational

Funder types: Industry

Identifiers

NCT07492277

CPH-80501

Details and patient eligibility

About

This study will serve to collect and analyze additional data on the use of the device croma revitalis for treatment of fine lines on the face including LCL and PR in the routine practice and as "real-world" performance.

Full description

This study is designed to observe the effects of croma revitalis, a medical device used to improve fine lines and skin quality, under real-life conditions. It is a prospective, open-label, non-comparative study, meaning all participants will receive the treatment, and both doctors and participants know what is being administered. This setup allows for efficient collection of clinical data while reflecting typical use in aesthetic practice. The study aims to evaluate improvements in skin concerns such as loss of volume, moisture, tone, and elasticity. The main way effectiveness will be measured is through the Global Aesthetic Improvement Scale (GAIS). This is a widely accepted 5-point scale used by doctors to assess visible improvements after treatment. The focus will be on improvements in areas such as lateral canthal lines (LCL), commonly known as "crow's feet", and perioral rhytides (PR), often referred to as "smile lines" or "smoker's lines." The primary evaluation point is Week 8, which is a typical follow-up period after a full treatment cycle consisting of three applications of the product. Participants will continue to be monitored until Week 24. The study plans to enroll approximately 70 participants, with the goal of collecting complete Week 8 data from at least 55 individuals.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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:

  1. Energy based device treatments that target collagen remodeling and/or production of collagen (e.g. laser therapy).
  2. Absorbable sutures (threads).
  3. HA or collagen dermal fillers.
  4. Botulinum toxin treatment.
  5. Facial lipolysis, including submental fat treatments.
  6. Facial plastic surgery.
  7. 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).