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

• ClinicalTrials.gov Identifier: NCT03550157
• Recruitment Status: Completed
• First Posted: June 8, 2018
• Last Update Posted: June 8, 2018
• Sponsor: Protein Supplies SL
• Information provided by (Responsible Party): Protein Supplies SL

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 110 Days
• Official Title: 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)
• Actual Study Start Date: September 27, 2016
• Actual Primary Completion Date: January 30, 2017
• Actual Study Completion Date: April 26, 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Thickness of the hypodermis reduction [ Time Frame: 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 ]
   Change in thickness of the hypodermis reduction measured by cutaneous ultrasound from baseline to end of treatment
2. Area of indentations reduction [ Time Frame: 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 ]
   Change in area of the indentations of the subcutaneous cellular tissue in the dermis from baseline to end of treatment measured by cutaneous ultrasound

Secondary Outcome Measures :

1. Total skin thickness reduction [ Time Frame: 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 ]
   Change in total skin thickness measured by cutaneous ultrasound from baseline to end of treatment
2. Thickness of dermis reduction [ Time Frame: 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 ]
   Change in total thickness of dermis measured by cutaneous ultrasound from baseline to end of treatment
3. Cellulite grade reduction [ Time Frame: 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 ]
   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.
4. Body weight reduction [ Time Frame: 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 ]
   Change in body weight from baseline to end of treatment
5. Body Mass Index reduction [ Time Frame: 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 ]
   Change in Body Mass Index from baseline to end of treatment
6. Skeletal muscle mass increase [ Time Frame: 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 ]
   Change in skeletal muscle mass from baseline to end of treatment
7. Body fat mass reduction [ Time Frame: 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 ]
   Change in body fat mass from baseline to end of treatment
8. Abdominal perimeter reduction [ Time Frame: 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 ]
   Change in abdominal perimeter (navel level) from baseline to end of treatment
9. Low abdominal perimeter reduction [ Time Frame: 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 ]
   Change in low abdominal perimeter (5 cm below navel) from baseline to end of treatment
10. Thigh perimeter reduction [ Time Frame: 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 ]
    Change in thigh perimeter from baseline to end of treatment
11. Number of Participants With Adverse Events [ Time Frame: 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 as a Measure of Safety and Tolerability

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cellulite or edematofibrosclerotic panniculopathy is a disorder that affects 85-98% of females after puberty and is considered a secondary sexual trait in females
• 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.

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

Contacts and Locations

Sponsors and Collaborators

Protein Supplies SL

Investigators

• Principal Investigator: Esther Roe, Ph; Hosptial de al Santa Creu i Sant pau

  Study Documents (Full-Text)

Documents provided by Protein Supplies SL:

Study Protocol and Statistical Analysis Plan  [PDF] May 5, 2016

More Information

Additional Information:

• Responsible Party: Protein Supplies SL
• ClinicalTrials.gov Identifier: NCT03550157
• Other Study ID Numbers: PNK-CEL-2016-06
• First Posted: June 8, 2018
• Last Update Posted: June 8, 2018
• Last Verified: October 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Protein Supplies SL:

Cellulite; Cutaneous ultrasound; PnKCelulitis® program

Additional relevant MeSH terms:

Cellulite; Skin Manifestations