Dysmorphic Disorder (BDD)NCT04936763
To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
A study testing Janesse 20 (Cross-linked Hyaluronic Acid) in people with Dysmorphic Disorder (BDD) and Congenital Labia Majora Hypotrophy, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmorphic Disorder (BDD), Congenital Labia Majora Hypotrophy, Post-menopausal Labia Majora Hypotrophy
- What is being tested?
- Janesse 20 (Cross-linked Hyaluronic Acid)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 May 2021to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Villa Serena
Genova
Andrea Maria Scarpa, MD
Romania1 site, 1 recruiting
- Recruiting
SCM Dr Rosu
Timișoara
Florina Todorut, MD
About this study
Official title: A Multicentre, Open-Label, Interventional, Trial To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
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.
- Conditions
- Dysmorphic Disorder (BDD), Congenital Labia Majora Hypotrophy, Post-menopausal Labia Majora Hypotrophy
- Being tested
- Janesse 20 (Cross-linked Hyaluronic Acid)
- Keywords
- Labia Majora, Genital rejuvenation, Hyaluronic Acid, Filler
- Medical subject headings
- Brachydactyly, Type D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Janesse 20 | Experimental | Not described Receives: Device: Janesse 20 (Cross-linked Hyaluronic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 60 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 30 days, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start28 May 2021
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Dysmorphic Disorder (BDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Sponsor type
- Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936763
- Sponsor's protocol ID
- OPIRA/0619/MD
- Status last verified
- Jul 2022
- First submitted
- 31 May 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28388734Bucknor 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.
PubMed 29342228Ouar N, Guillier D, Moris V, Revol M, Francois C, Cristofari S. [Postoperative complications of labia minora reduction. Comparative study between wedge and edge resection]. Ann Chir Plast Esthet. 2017 Jun;62(3):219-223. doi: 10.1016/j.anplas.2017.02.005. Epub 2017 Mar 9. French.
PubMed 28285885Vanaman M, Bolton J, Placik O, Fabi SG. Emerging Trends in Nonsurgical Female Genital Rejuvenation. Dermatol Surg. 2016 Sep;42(9):1019-29. doi: 10.1097/DSS.0000000000000697.
PubMed 27153040Hunter JG. Labia Minora, Labia Majora, and Clitoral Hood Alteration: Experience-Based Recommendations. Aesthet Surg J. 2016 Jan;36(1):71-9. doi: 10.1093/asj/sjv092. Epub 2015 Oct 24.
PubMed 26499942Sharp G, Mattiske J, Vale KI. Motivations, Expectations, and Experiences of Labiaplasty: A Qualitative Study. Aesthet Surg J. 2016 Sep;36(8):920-8. doi: 10.1093/asj/sjw014. Epub 2016 Feb 23.
PubMed 26912581Sorice SC, Li AY, Canales FL, Furnas HJ. Why Women Request Labiaplasty. Plast Reconstr Surg. 2017 Apr;139(4):856-863. doi: 10.1097/PRS.0000000000003181.
PubMed 28350660Sharp G, Tiggemann M, Mattiske J. Factors That Influence the Decision to Undergo Labiaplasty: Media, Relationships, and Psychological Well-Being. Aesthet Surg J. 2016 Apr;36(4):469-78. doi: 10.1093/asj/sjv270. Epub 2016 Feb 18.
PubMed 26893523Goodman MP, Placik OJ, Benson RH 3rd, Miklos JR, Moore RD, Jason RA, Matlock DL, Simopoulos AF, Stern BH, Stanton RA, Kolb SE, Gonzalez F. A large multicenter outcome study of female genital plastic surgery. J Sex Med. 2010 Apr;7(4 Pt 1):1565-77. doi: 10.1111/j.1743-6109.2009.01573.x. Epub 2009 Nov 12.
PubMed 19912495Veale D, Eshkevari E, Ellison N, Costa A, Robinson D, Kavouni A, Cardozo L. A comparison of risk factors for women seeking labiaplasty compared to those not seeking labiaplasty. Body Image. 2014 Jan;11(1):57-62. doi: 10.1016/j.bodyim.2013.10.003. Epub 2013 Nov 14.
PubMed 24239491Jackson TD, Grilo CM, Masheb RM. Teasing history, onset of obesity, current eating disorder psychopathology, body dissatisfaction, and psychological functioning in binge eating disorder. Obes Res. 2000 Sep;8(6):451-8. doi: 10.1038/oby.2000.56.
PubMed 11011912de Jong PJ, van Overveld M, Schultz WW, Peters ML, Buwalda FM. Disgust and contamination sensitivity in vaginismus and dyspareunia. Arch Sex Behav. 2009 Apr;38(2):244-52. doi: 10.1007/s10508-007-9240-x. Epub 2007 Oct 2.
PubMed 17909958Hamori CA. Discussion: Why Women Request Labiaplasty. Plast Reconstr Surg. 2017 Apr;139(4):864. doi: 10.1097/PRS.0000000000003183. No abstract available.
PubMed 28350661Berreni N. Augmentation of the Labia Majora With Fillers. In: Hamori CA, Banwel PE, Alinsod R, editors. Female Cosmetic Genital Surgery: concepts, classification, and techniques. New York: Thieme Medical Publishers, Inc; 2017. p 125-142.
Jabbour S, Kechichian E, Hersant B, Levan P, El Hachem L, Noel W, Nasr M. Labia Majora Augmentation: A Systematic Review of the Literature. Aesthet Surg J. 2017 Oct 16;37(10):1157-1164. doi: 10.1093/asj/sjx056.
PubMed 28449124
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-Label, Interventional, Trial To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
- ClinicalTrials.gov ID
- NCT04936763
- Acronym / sponsor ID
- OPIRA/0619/MD
- Conditions
- Dysmorphic Disorder (BDD), Congenital Labia Majora Hypotrophy, Post-menopausal Labia Majora Hypotrophy
- Keywords
- Labia Majora, Genital rejuvenation, Hyaluronic Acid, Filler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 28 May 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Janesse 20 | Experimental | Device: Janesse 20 (Cross-linked Hyaluronic Acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Janesse 20 |
Primary outcome
Global Aesthetic Improvement Scale (GAIS)
Time frame: 60 days
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.
Overall safety
Time frame: up to 60 days
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.
3 secondary outcomes
Dimensions of Labia Majora
Time frame: 30 days, 60 days
Genital Appearance Satisfaction (GAS)
Time frame: 30 days, 60 days
Global Aesthetic Improvement Scale (GAIS)
Time frame: 30 days, 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 28388734Cosmetic Surgery National Data Bank Statistics. Aesthet Surg J. 2017 May 1;37(suppl_2):1-29. doi: 10.1093/asj/sjx076. No abstract available.
- Background: PubMed 29342228Bucknor 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.
- Background: PubMed 28285885Ouar N, Guillier D, Moris V, Revol M, Francois C, Cristofari S. [Postoperative complications of labia minora reduction. Comparative study between wedge and edge resection]. Ann Chir Plast Esthet. 2017 Jun;62(3):219-223. doi: 10.1016/j.anplas.2017.02.005. Epub 2017 Mar 9. French.
- Background: PubMed 27153040Vanaman M, Bolton J, Placik O, Fabi SG. Emerging Trends in Nonsurgical Female Genital Rejuvenation. Dermatol Surg. 2016 Sep;42(9):1019-29. doi: 10.1097/DSS.0000000000000697.
- Background: PubMed 26499942Hunter JG. Labia Minora, Labia Majora, and Clitoral Hood Alteration: Experience-Based Recommendations. Aesthet Surg J. 2016 Jan;36(1):71-9. doi: 10.1093/asj/sjv092. Epub 2015 Oct 24.
- Background: PubMed 26912581Sharp G, Mattiske J, Vale KI. Motivations, Expectations, and Experiences of Labiaplasty: A Qualitative Study. Aesthet Surg J. 2016 Sep;36(8):920-8. doi: 10.1093/asj/sjw014. Epub 2016 Feb 23.
- Background: PubMed 28350660Sorice SC, Li AY, Canales FL, Furnas HJ. Why Women Request Labiaplasty. Plast Reconstr Surg. 2017 Apr;139(4):856-863. doi: 10.1097/PRS.0000000000003181.
- Background: PubMed 26893523Sharp G, Tiggemann M, Mattiske J. Factors That Influence the Decision to Undergo Labiaplasty: Media, Relationships, and Psychological Well-Being. Aesthet Surg J. 2016 Apr;36(4):469-78. doi: 10.1093/asj/sjv270. Epub 2016 Feb 18.
- Background: PubMed 19912495Goodman MP, Placik OJ, Benson RH 3rd, Miklos JR, Moore RD, Jason RA, Matlock DL, Simopoulos AF, Stern BH, Stanton RA, Kolb SE, Gonzalez F. A large multicenter outcome study of female genital plastic surgery. J Sex Med. 2010 Apr;7(4 Pt 1):1565-77. doi: 10.1111/j.1743-6109.2009.01573.x. Epub 2009 Nov 12.
- Background: PubMed 24239491Veale D, Eshkevari E, Ellison N, Costa A, Robinson D, Kavouni A, Cardozo L. A comparison of risk factors for women seeking labiaplasty compared to those not seeking labiaplasty. Body Image. 2014 Jan;11(1):57-62. doi: 10.1016/j.bodyim.2013.10.003. Epub 2013 Nov 14.
- Background: PubMed 11011912Jackson TD, Grilo CM, Masheb RM. Teasing history, onset of obesity, current eating disorder psychopathology, body dissatisfaction, and psychological functioning in binge eating disorder. Obes Res. 2000 Sep;8(6):451-8. doi: 10.1038/oby.2000.56.
- Background: PubMed 17909958de Jong PJ, van Overveld M, Schultz WW, Peters ML, Buwalda FM. Disgust and contamination sensitivity in vaginismus and dyspareunia. Arch Sex Behav. 2009 Apr;38(2):244-52. doi: 10.1007/s10508-007-9240-x. Epub 2007 Oct 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Janesse 20 (Cross-linked Hyaluronic Acid) in people with Dysmorphic Disorder (BDD) and Congenital Labia Majora Hypotrophy, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dionisio F Barattini, MD Europe (+40774012684, franco.barattini@tigermedgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936763, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.