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Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

NCT ID: NCT03050749

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-20

Study Completion Date

2018-03-06

Brief Summary

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In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed appropriate by the Investigator.

Detailed Description

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Conditions

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Facial Lipoatrophy Morphological Asymmetry of the Face Debilitating Scars

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Princess® VOLUME
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Princess® VOLUME

Group Type OTHER

Princess® VOLUME

Intervention Type DEVICE

Princess® VOLUME injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.

Interventions

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Princess® VOLUME

Princess® VOLUME injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female 18 years of age or older
* Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or

* Morphological asymmetry of the face, or
* One or more debilitating scars on the face
* Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
* Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.

Exclusion Criteria

* Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only)
* History of allergic reaction or hypersensitivity to hyaluronic acid
* History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
* Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last six months
* Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention
* Treatment with anticoagulant or antiplatelet drugs
* Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
* Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
* Institutionalized persons with legally limited civil rights
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Croma-Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daisy Kopera, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz, Austria

Locations

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Medical University Graz

Graz, , Austria

Site Status

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, , Austria

Site Status

Ordination Dr. Benjamin Gehl

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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CPH-401-201260

Identifier Type: -

Identifier Source: org_study_id