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

A Pilot Study of Cutaneous Ultrasound Evaluation of Structural Changes in Subcutaneous Tissue in Patients With Cellulitis After Multidisciplinary Treatment to Combat Cellulitis (PnKCelulitis® Program)

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.

Study Overview

• Status: Completed
• Conditions: Cellulite

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.

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of the hypodermis reduction	Change in thickness of the hypodermis reduction measured by cutaneous ultrasound from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Area of indentations reduction	Change in area of the indentations of the subcutaneous cellular tissue in the dermis from baseline to end of treatment measured by cutaneous ultrasound	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total skin thickness reduction	Change in total skin thickness measured by cutaneous ultrasound from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Thickness of dermis reduction	Change in total thickness of dermis measured by cutaneous ultrasound from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Cellulite grade reduction	Change in the degree of cellulitis according to the Nürnberger-Muller classification scale from the beginning to the end of the treatment. It is a simple grading-score of cellulite by inspection (grade 0= Smooth surface of skin while lying down and standing and wrinkles upon pinch-test; grade 1=Smooth surface of skin while lying down and standing, mattress-phenomenon upon pinch-test; grade 2=Mattress-phenomenon spontaneously while standing and grade 3=Mattress-phenomenon spontaneously while standing and lying down). A higher score indicates a higher severity of cellulite.	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Body weight reduction	Change in body weight from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Body Mass Index reduction	Change in Body Mass Index from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Skeletal muscle mass increase	Change in skeletal muscle mass from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Body fat mass reduction	Change in body fat mass from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Abdominal perimeter reduction	Change in abdominal perimeter (navel level) from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Low abdominal perimeter reduction	Change in low abdominal perimeter (5 cm below navel) from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Thigh perimeter reduction	Change in thigh perimeter from baseline to end of treatment	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3
Number of Participants With Adverse Events	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	from the beginning to the end of treatment, an average of 8±1 weeks in patients with grade 1, an average of 10±1 weeks in patients with grade 2 and an average of 14±1 weeks for patients with grade 3

Collaborators and Investigators

• Sponsor: Protein Supplies SL

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2016
• Primary Completion (Actual): January 30, 2017
• Study Completion (Actual): April 26, 2017

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cellulite; Cutaneous ultrasound; PnKCelulitis® program
• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: PNK-CEL-2016-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No