An interventional study of Janesse 20 (Cross-linked Hyaluronic Acid) in Dysmorphic Disorder (BDD), Congenital Labia Majora Hypotrophy and Post-menopausal Labia Majora Hypotrophy, sponsored by I.R.A. Istituto Ricerche Applicate S.p.A.. Status unknown at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by I.R.A. Istituto Ricerche Applicate S.p.A. · Not applicable, Interventional, and Treatment
The use of hyaluronic acid (HA)-based fillers administered by injection to obtain Labia Majora augmentation is performed by many surgeons and gynaecologists in Europe, US and other countries, but few studies have investigated the effectiveness of this procedure. In this open not comparative study, 36 female subjects above or equal to 18 years old at inclusion, seeking genital rejuvenation, who have congenital or post-menopausal hypotrophy of the vulvar Labia Majora (or a diagnosis of Body Dysmorphic Disorder), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 4 visits over a period of 2 months.
The primary objective of the study is to evaluate the performance of the dermal filler by the Global Aesthetic Improvement Scale (GAIS) at day 60 and the safety during all the study. The secondary objectives are the evaluation of volume restoration of Labia Majora (measured by caliper and Ultrasound) and the subjective evaluation (by Genital Appearance Satisfaction Scale) at different visits.
I.R.A. Istituto Ricerche Applicate S.p.A. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Janesse 20 (Cross-linked Hyaluronic Acid)
Janesse 20 will be administered at baseline (visit 2, day 0) and, if the Investigator will evaluate necessary, also at day 30 (visit 3). The Investigational device will be injected with retrograde technique (moving backward) with homogeneous amount on the length of each side of Labia Majora. The Janesse 20 dosage administered will be 1 ml in left labia and 1 ml in right labia for each session.
Global Aesthetic Improvement Scale (GAIS)
Global Aesthetic Improvement Scale (GAIS) is will be evaluated by the investigator using standardized photos. The scale is using scores as 1= VERY MUCH IMPROVED, 2= MUCH IMPROVED, 3 = IMPROVED, 4 = NO CHANGE, 5= WORSE. The picture will be done at 60 days after the initiation of treatment with Janesse 20, will be compared with Baseline Visit (day 0) and one of the above-mentioned scores will be gibed used to indicate the changes after the treatment.
Time frame: 60 days
Overall safety
The overall safety will be evaluated by safety checklist for the patient (modified from Liu S, 2010) and the searching of Adverse Event (s), Adverse Device Event (s), Serious Adverse Event (s), Serious Adverse Device Event (s), Unanticipated Serious Adverse Device Event (s) and Device Deficiency at each visit.
Time frame: up to 60 days
Dimensions of Labia Majora
The measurement will be performed with the subject in lithotomy position at the different visits using a Sliding Zuricher Caliper mm130 for length and width; the ultrasound technique will be used to evaluate the depth.
Time frame: 30 days, 60 days
Genital Appearance Satisfaction (GAS)
Genital Appearance Satisfaction (GAS) self-assessment of the subject to assess the change comparing the final and baseline value. The scale contains 11 statements regarding attitudes towards genital appearance. Each item is scored on a Likert scale between 0 (="NEVER") and 3 =("ALWAYS"). Total scores range from 0 to 33. Higher scores represent greater dissatisfaction with the genitalia.
Time frame: 30 days, 60 days
Global Aesthetic Improvement Scale (GAIS)
Global Aesthetic Improvement Scale (GAIS) evaluated by blind Investigator, using scores 1= VERY MUCH IMPROVED, 2= MUCH IMPROVED, 3 = IMPROVED, 4 = NO CHANGE, 5= WORSE.
Time frame: 30 days, 60 days
Explorative outcome (Labia Majora volume)
The validation of measurements of Labia Majora volume by a 3D software during the study period comparing these values with the dimensions obtained with ultrasound (for depth) and caliper (for lenght and width). Tridimensional surface imaging for estimating Labia Majora volume using Crisalix iPad App and the Crisalix 3D Surface Imager Camera will be evaluated by blind Investigator at different visits. The data will be collected and evaluated in 1 center only (Genova).
Time frame: 30 days, 60 days
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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I.R.A. Istituto Ricerche Applicate S.p.A.