Structural Changes of Subcutaneous Tissue by Ultrasonographies in Patients After Treatment With PnKCelulitis® Program

NCT ID: NCT03550157

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2017-04-26

Brief Summary

Exploratory, prospective, uncontrolled and single-blinded pilot study, with clinical and ultrasound assessments of cutaneous cellulite before and after treatment with a specific multidisciplinary programme following dietary guidelines, physical exercise and the application of a cosmetic cream.

Detailed Description

Females older than 18, with normal weight ranges in addition to the presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy), were recruited for the study and to undergo treatment with the multidisciplinary programme.

All patients were treated with the specific multidisciplinary programme for cellulite (PnKCelulitis®). This programme consists of three phases or processes: the restructuring, drainage and toning processes, each of which combines diet, physical exercise and the application of an anti-cellulite cream that combines active lipolytic and vasodilator agents (Cellulite Gel K-Line®).

Patient's clinical assessment follow-up was performed by the prescribing doctor for the multidisciplinary treatment and was done in four visits: baseline (before starting treatment) and at the end of each of the phases (restructuring, drainage and toning). Anthropometric data were recorded at each visit and a bioelectric impedance test to assess body composition (amount of fat mass and muscle mass). The clinical evaluation of the degree of cellulite was made according to the Nürnberger-Muller classification scale.

Cutaneous ultrasound was performed by an expert dermatologist in the dermatology outpatient clinic of the hospital and subsequently assessed blinded. Two skin scans were done for each patient, one before starting the treatment and another at the end. The objective data collected on each ultrasound were total skin thickness, thickness of the dermis and hipodermis, the area of the indentations of the subcutaneous cellular tissue in the dermis and changes in the echogenicity of the dermis blinded and independently assessed by two researchers, comparing ultrasounds before and after treatment.

Conditions

Cellulite

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Females older than 18 years
• Normal weight ranges
• Presence of cutaneous non-infectious cellulite (edematous-fibrosclerotic panniculopathy)
• Women who are going to begin treatment with the multidisciplinary programme

Exclusion Criteria

• Pregnant or lactating females
• Contraindications of a ketogenic diet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Protein Supplies SL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Roe, Ph

Role: PRINCIPAL_INVESTIGATOR

Hosptial de al Santa Creu i Sant pau

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PNK-CEL-2016-06

Identifier Type: -

Identifier Source: org_study_id