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

NCT07492277 | Active Not Recruiting

• 1 other identifier: CPH-80501
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Canthal Lines (LCL); Perioral Rhytids

Keywords

Facial wrinkles; Fine lines; Crow's feet; Smile lines; Perioral rhytides; Lateral canthal lines; Dermal filler

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Physician Assessment

  Weeks 3, 6, 12, and 24 after initial treatment

• Responder Status Based on the Global Aesthetic Improvement Scale (GAIS) - Independent Evaluator Panel

  Weeks 3, 6, 12, and 24 after initial treatment

• Change in Skin Hydration from Baseline Measured by Corneometer

  Week 3, 6, 8, 12, and 24

• Change in Skin Tone from Baseline Measured by Cutometer

  Week 3, 6, 8, 12, and 24

• Change in Skin Elasticity from Baseline Measured by Cutometer

  Week 3, 6, 8, 12, and 24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults seeking aesthetic treatment for fine lines, such as crow's feet and smile lines. Participants will be generally healthy and representative of typical dermal filler users in routine clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (1)

Yuvell

Vienna, 1010, Austria

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 25, 2026
• Study Start: January 16, 2026
• Primary Completion: June 9, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)