Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators (Biostimulation)

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers

Treatments: Procedure: Poly-L-Lactic Acid (Sculptra) injection; Procedure: Radiofrequency Microneedling; Procedure: Calcium Hydroxyapatite

Study type: Interventional

Funder types: Other

Identifiers

NCT06993558

University Hamburg Eppendorf (Other Identifier)

2024-101412-BO-ff

Details and patient eligibility

About

The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit/ and energy-based (Radiofrequency Microneedling) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are:

How is the Safety Profile of Biostimulatory Treatments? How are the Tissue Interactions after Biostiomulatory Treatments?

Participants will:

• Recieve one of 3 possible biostumulatory treatments (PLLA/CAHA/RFM)
• Attend 5 follow-up appointments after treatment for checkups, surveillance and examinations.

Full description

Patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.

Participants will be assigned to one of three treatment groups:

1. PLLA (Sculptra®, Sinclair Pharmaceuticals)
2. CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan)
3. RFMN (Genius®, Lutronic Medical Systems)

Treatment Protocols:

• PLLA: 1-3 sessions at intervals of 4-6 weeks
• CaHA: Single session
• RFMN: 1-3 sessions at intervals of 6-8 weeks

These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.

Follow-Up Assessments

Patients will undergo follow-up evaluations at 5 defined time points after treatment:

1. 6 weeks

2. 6 months

3. 12 months 4.18 months

4. 24 months

Enrollment: 90 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

-Inclusion Criteria:

Men and women aged 30 years and older

Good general health, no relevant pre-existing conditions

Patients planning to undergo CaHa, PLLA, or RFMN treatment as part of routine care due to skin laxity or volume loss

Cognitive ability and willingness to provide informed consent

Willingness and ability to attend follow-up visits

-Exclusion Criteria:

Age under 30 years

Pregnant or breastfeeding individuals

Significant open wounds or lesions in the treatment area

Metallic implants in the treatment area

Psychiatric disorders (psychosis, body dysmorphic disorders)

Missing informed consent and/or data privacy declarations

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Injectable Biostimulator 1

Experimental group

Description:

Injection to the face with a blunt canula

Treatment:

Procedure: Poly-L-Lactic Acid (Sculptra) injection

Injectable Biostimulator 2

Experimental group

Description:

Will be injected to the face with blunt canula

Treatment:

Procedure: Calcium Hydroxyapatite

Energy-based Biostimulator

Experimental group

Description:

1-3 Treatments with 6-8 weeks of intervall

Treatment:

Procedure: Radiofrequency Microneedling