To Assess The Performance And Tolerance Of Janesse 20 In... | NCT04936763

Status Module

Name	Class
Opera CRO, a TIGERMED Group Company	OTHER

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Janesse 20	Experimental		Device: Janesse 20 (Cross-linked Hyaluronic Acid)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Janesse 20 (Cross-linked Hyaluronic Acid)	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	up to 60 days

Secondary Outcomes

Measure	Description	Time Frame
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.	30 days, 60 days
Genital Appearance Satisfaction (GAS)

Other Outcomes

Measure	Description	Time Frame
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).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with age ≥ 18.
Women seeking genital rejuvenation with Genital Appearance Satisfaction Scale (GAS) >20 and Cosmetic Procedure Screening Scale modified for Labia (COPS-L)>40 .
Patients with diagnosis of Body Dysmorphic Disorder (BDD) following DSM-IV criteria or congenital or post-menopausal Labia Majora hypotrophy
• The Labia Majora (left and right) width and/or length must be between the 5th and 95th percentiles as reported in the Annex 4 of the protocol (modified table from Kreklau A e t al 2018). The measurement must be performed by the Investigators using the Sliding Zuricher Caliper mm130.
Women willing to provide signed informed consent to clinical investigation participation.

Exclusion Criteria:

Use of aspirin and antiplatelet agents a week prior to treatment.
Pregnant or lactating women.
Women with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler.
Women with history of allergy or hypersensitivity to Lidocaine, Mepivacaine or Prilocaine or local anaesthetics.
Women with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.
Women presenting bleeding disorders in the past or present.
Women taking or having indications for anticoagulant therapy.
Use of concomitant treatments or procedures aimed to improve genital skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing.
Women suffering from infectious diseases including herpes simplex virus infection, active hepatitis, Human Papilloma Virus (HPV) or Human Immunodeficiency Virus (HIV).
Women suffering from local dermatitis (vulvar scaly papilloma, mycosis, bacterial infection near the injection area).
Women at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device.
Women with autoimmune diseases, streptococcus disease.
Women with any active irritation or inflammation in the target areas of injection.
Recent vulvae surgery in the treatment area or progressive recent or nearby cancers (i.e. cervical cancer).
Tachycardia or other severe heart rhythm disorders
Women with previous regional radiotherapy.
Women who practice cycling or dedicate themselves to horse riding; women who practice bodybuilding or who perform professional sports.
Women unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
Performed dentist visit in the last week.
Women participating in another clinical investigation or treated with another HA filler with the same indications at the same time or within the preceding 30 days.

PubMed Identifier	Type	Citation	Retractions
28388734	Background	Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2017 May 1;37(suppl_2):1-29. doi: 10.1093/asj/sjx076. No abstract available.
29342228	Background	Bucknor A, Chen AD, Egeler S, Bletsis P, Johnson AR, Myette K, Lin SJ, Hamori CA. Labiaplasty: Indications and Predictors of Postoperative Sequelae in 451 Consecutive Cases. Aesthet Surg J. 2018 May 15;38(6):644-653. doi: 10.1093/asj/sjx241.