To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.
The study will be conducted as a single centre, randomized, double-blind, controlled, parallel group study with healthy female volunteers, aged 18-45 years of age, with skin phototypes I to VI and a clinical diagnosis of cellulite on buttocks (at least score 6 at Cellulite Severity Scale (CSS)). The study will take 24 weeks (6 months) per subject. There will be one previsit during the screening phase and 8 visits per subject during the treatment phase. Safety and efficacy variables will be performed monthly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
oral, twice daily in morning and evening for 6 months
oral, twice daily in morning and evening for 6 months
CBED: Brazilian Center for Studies in dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Clinical biochemistry (hematology, blood chemistry, blood coagulation)
change in clinical biochemistry at 6 months vs baseline
Time frame: 6 months
vital signs
change in clinical examination at 6 months vs baseline
Time frame: 6 months
adverse events and tolerability
change in number of persons with adverse events at 6 months vs baseline
Time frame: 6 months
cellulite severity
change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements
Time frame: Day 1, 7, 30, 60, 90, 120, 150, 180
Thigh circumference
Change in thigh circumferences below gluteus fold within repeated measurements, Change in thigh circumferences above the upper part of the knee within repeated measurements
Time frame: Day 1, 7, 30, 60, 90, 120, 150, 180
Digital photography
Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1
Time frame: Day 1, Day 90, Day 180
Ultrasound sonography
Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1
Time frame: Day 1, Day 90 and Day 180
Magnetic resonance
change in adipose tissue Day 180 vs Day 1
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Time frame: Day 1 and Day 180
satisfaction questionnaire
Improvement in patient satisfaction
Time frame: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
dermatology life quality index
Improvements in the parameters of quality of life
Time frame: day 1, 30, 60, 90, 120, 150, 180
celluquol questionnaire
each question in repeated measurements
Time frame: day 1, 30, 60, 90, 120, 150, 180
cutometry
change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1
Time frame: day 1, 90, 180
corneometry
change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1
Time frame: day 1, 90, 180
skin profilometry
change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1
Time frame: day 1, 90, 180
liquichip analysis
change in inflammatory markers day 180 vs day 1
Time frame: day 1, day 180