Facial lipodystrophy
Conditions
Interventions
Group 1: 22 subjects will receive an injectable triamcinolone acetonide commercial preparation diluted in an anesthetic solution containing lidocaine associated to vasoconstrictor. There will be three
one per month.
Group 2: 22 subjects will receive an injectable triamcinolone acetonide commercial preparation diluted in an anesthetic solution containing lidocaine only. There will be three sessions
one per month.
Group 3: 11 subjects will be submitted to 4 radiofrequency sessions
one session per month.
Drug
Procedure/surgery
A10.165.114.830.750
Sponsors
Centro Brasileiro de Estudos em Dermatologia
Centro Brasileiro de Estudos em Dermatologia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Signed ICF; Subjects aged 18 years or older with clinical indication for study treatments; Medical history and physical examination that, in the opinion of the investigator, does not interfere with the progress of the study; Women of childbearing potential should have a negative urinary pregnancy test at visit 1. These subjects should use a highly effective contraception method during the study (combined oral contraceptives [estrogen and progesterone] or implanted contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to entry into the study and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry) or use of condom; Women presenting for childbearing potential (eg, before menstruation, post menopause (absence of menstrual bleeding for 1 year before entry into the study), hysterectomy, or bilateral ovariectomy, less than one year postmenopausal); Accumulation of fat in the submental area and perimandibular area posterior to the melomental sulcus; Body Mass Index (BMI = weight/height2) from 18.5 to 29.9 kg/m2; Availability to maintain stable weight throughout the study period (maximum variation of 5% of total body weight throughout the study); Understand and sign the Informed Consent Term (ICF) before any study procedure is performed; Availability and ability to comply with protocol requirements and study duration.
Exclusion criteria
Exclusion criteria: Pregnant and/or breastfeeding women, or women who wish to become pregnant during the study period; Participation in another clinical study less than 30 days before the start of the present study; Presence of scars or other marks on the face that may interfere with the evaluation of results; Treatments and/or procedures based on lasers, lights and waves to improve the facial contour less than 6 months before the beginning of the study; History (less than 36 months) or planning treatment with poly-L-lactic acid on the face; History (less than 12 months) or plan treatment with hyaluronic acid or other non-permanent fillers on the face; History or planning treatment with permanent fillers on the face; Any previous surgical intervention or during the study to improve facial contour; Contraindications to perform MRI, as specified by the radiology service where the examination will be performed, such as claustrophobia, presence of metallic implants, recent tattoos; Smoking; Neoplastic diseases, osteoporosis, diabetes mellitus, cutis laxa and / or collagen diseases, Cushing's syndrome, glaucoma; Under use or having used the following treatments within the time period specified prior to visit 1: Anticholinesterases, cholestyramine, ketoconazole (7 days) Aminoglutethimide, amphotericin B, potassium-depleting diuretics, oral anticoagulants, antidiabetics, tuberculostatic drugs, cyclosporine, digitalis glycosides, barbiturates, phenytoin, carbamazepine (30 days); Untreated cardiovascular or endocrine diseases; Coagulation disorders; Inflammations or infections in the study area; History of sensitivity to components of the formula; Intense cutaneous flaccidity, which in the opinion of the investigator, may interfere with the results of the study; Any disease or condition that, in the opinion of the investigator, may interfere with the assessments or participation in the study; Subjects with history of non-adherence to medications or showing difficulties to adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Fat volume (cm3) and fat thickness (mm) reduction in the treated areas, assessed by magnetic resonance imaging (MRI), considering the proportion of subjects with at least 10% fat volume (cm³) reduction, comparing pre- versus post-intervention* measures. *The “post-procedure” timepoint herein mentioned refers to visit 5, to be performed 2 months after the last treatment session for the active groups and 1 month after the last treatment session for the placebo group.;Observed outcome 1: Submental area • Group 1: 58.8% (n=10) • Group 2: 47.1% (n=8) • Group 3: 63.6% (n=7) Perimandibular right area • Group 1: 50.0% (n=9) • Group 2: 58.8% (n=10) • Group 3: 45.5% (n=5) Perimandibular left area • Group 1: 55.6% (n=10) • Group 2: 58.8% (n=10) • Group 3: 72.7% (n=8);Expected outcome 2: Fat volume (cm3) and fat thickness (mm) reduction in the treated areas, assessed by MRI exams, considering the mean percentage of volume (cm3) and thickness (mm) reduction, comparing pre- versus post-intervention* measures. *The “post-procedure” timepoint herein mentioned refers to visit 5, to be performed 2 months after the last treatment session for the active groups and 1 month after the last treatment session for the placebo group.;Observed outcome 2: Fat volume (cm3) reduction Submental area • Group 1: 9.7% • Group 2: 10.7% • Group 3: 13.7% Perimandibular right area • Group 1: 10.8% • Group 2: 17.1% • Group 3: 4.8% Perimandibular left area • Group 1: 12.4% • Group 2: 16.3% • Group 3: 14.2% Fat thickness (mm) reduction Submental area • Group 1: 8.1% • Group 2: 2.2% • Group 3: 5.8% Perimandibular right area • Group 1: 8.6% • Group 2: 8.3% • Group 3: 6.2% Perimandibular left area • Group 1: 5.9% • Group 2: 6.4% • Group 3: 12.0% ;Expected outcome 3: Reduction of the serum cortisol levels, assessed by lab exams 24 hours after the treatment sessions, considering the proportion of subjects presenting serum cortisol levels below the minimum limit established by t | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Fat thickness (mm) reduction in the treated areas, assessed by skinfold caliper, considering the mean percentage of thickness (mm) reduction, comparing pre- versus post-intervention* measures. *The “post-procedure” timepoint herein mentioned refers to visit 5, to be performed 2 months after the last treatment session for the active groups and 1 month after the last treatment session for the placebo group.;Observed outcome 1: Fat thickness (mm) reduction Submental area • Group 1: 25.1% • Group 2: 23.2% • Group 3: 27.8% Perimandibular right area • Group 1: 17.4% • Group 2: 20.3% • Group 3: 23.0% Perimandibular left area • Group 1: 16.3% • Group 2: 18.0% • Group 3: 19.4% ;Expected outcome 2: Global aesthetic improvement, assessed by the Global Aesthetic Improvement Scale (GAIS), observing the percentage of cases “improved”, “much improved” and “very much improved”. Assessment done by the investigator at the post-procedure visit*. *The “post-procedure” timepoint herein mentioned refers to visit 5, to be performed 2 months after the last treatment session for the active groups and 1 month after the last treatment session for the placebo group.;Observed outcome 2: Investigators considered most of the subjects improved in group 1 (66.6%, n= 12), group 2 (73.7%, n=13), and in group 3 (54.6%, n=6). Global aesthetic improvement assessed by the investigators was similar between groups. ;Expected outcome 3: Global aesthetic improvement, assessed by the Global Aesthetic Improvement Scale (GAIS), observing the percentage of cases “improved”, “much improved” and “very much improved”. Assessment done by the subjects at the post-procedure visit*. *The “post-procedure” timepoint herein mentioned refers to visit 5, to be performed 2 months after the last treatment session for the active groups and 1 month after the last treatment session for the placebo group.;Observed outcome 3: Most of the subjects of group 1 (94.4%, n=17), group 2 (89.5% | — |
Countries
Brazil
Contacts
Public ContactCarolina Siega
Centro Brasileiro de Estudos em Dermatologia
Outcome results
None listed