Croma Revitalis for correcting fine facial lines

A Non-Interventional, Post-Market-Clinical-Follow up (PMCF), Prospective, Open-Label, Single-Center Observational Study Evaluating Croma Revitalis in Correction of Fine Lines

This project will try Croma Revitalis on adults with crow's feet or perioral lines to see if it improves fine facial lines and overall skin quality.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Croma-Pharma GmbH (industry)
• Locations: 1 site (Vienna)
• Trial ID: NCT07492277 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, non-comparative observational program in which all participants receive Croma Revitalis and both clinicians and participants know the treatment. Effectiveness will be measured mainly by the Global Aesthetic Improvement Scale (GAIS) with a primary evaluation at Week 8 after a full treatment cycle of three product applications. Participants will be followed up through Week 24 to collect real-world safety and performance data. The study plans to enroll about 70 participants with the goal of having at least 55 complete the Week 8 evaluation to support analysis.

Who should consider this trial

Good fit: Adults aged 18 or older with lateral canthal lines and/or perioral rhytides judged by their treating physician to merit treatment, who have generally healthy facial skin and can attend routine follow-up visits, are ideal candidates.

Not a fit: People who tend to develop hypertrophic scars, have pigment disorders or other skin conditions that interfere with cutaneous aging evaluation, or who need surgical correction are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could provide a minimally invasive option to reduce fine facial lines and improve skin moisture, tone, and elasticity.

How similar studies have performed: Similar injectable skin‑booster devices and observational programs have shown modest improvements in fine lines and skin quality in prior studies.

Eligibility criteria

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).

Where this trial is running

Vienna

• Yuvell — Vienna, Austria (RECRUITING)

Study contacts

• Study coordinator: Head of Clinical Operations

Conditions: Lateral Canthal Lines, Perioral Rhytids, Facial wrinkles, Fine lines, Crow's feet, Smile lines, Perioral rhytides, Lateral canthal lines