NCT03550157

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
Last Updated

April 26, 2023

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

May 8, 2018

Last Update Submit

April 25, 2023

Conditions

Cellulite

Keywords

CelluliteCutaneous ultrasoundPnKCelulitis® program

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • Total skin thickness reduction

    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

    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

    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

    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

    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

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCellulite or edematofibrosclerotic panniculopathy is a disorder that affects 85-98% of females after puberty and is considered a secondary sexual trait in females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating females
  • Contraindications of a ketogenic diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esther Roe, Ph

    Hosptial de al Santa Creu i Sant pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
110 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

June 8, 2018

Study Start

September 27, 2016

Primary Completion

January 30, 2017

Study Completion

April 26, 2017

Last Updated

April 26, 2023

Record last verified: 2017-10