Safety and efficacy of a Injectable Triamcinolone Acetonide commercial preparation for the treatment of facial fat deposits

Not Applicable

• Conditions: Facial lipodystrophy; E88.1

• Registration Number: RBR-3wz9b2
• Lead Sponsor: Centro Brasileiro de Estudos em Dermatologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified