So... How was JUVÉDERM VOLUMA® XC studied? Here you will find just several clinical studies about the product in order to improve your understanding about it in a practical way. The first study is presented by Allergan, which is a manufacturer of JUVÉDERM VOLUMA® XC. The research is mainly focused on the product by itself disregarding where it has been injected.
The 1st Study Presented
To establish the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel, 270 subjects (80% female and 20% male) were treated. To achieve subjects’ desired results, a touch-up treatment was allowed 1 month after initial treatment. After 2 years or after correction had been lost, whichever was first, subjects were offered an optional repeat treatment.
The amount of JUVÉDERM VOLUMA® XC injectable gel used in the clinical study to achieve optimal outcomes ranged from 1.2 mL to 13.9 mL, with a median volume of 6.6 mL. In general, the amount of JUVÉDERM VOLUMA® XC used for the touch-up and repeat treatment was significantly less than the first treatment. For each patient the volume used was based on volume deficit and treatment goals.
To evaluate the safety of JUVÉDERM VOLUMA® XC injectable gel, subjects noted common side effects in daily diaries. Side effects were also reported by doctors based on office visits with each subject. These office visits included discussing any symptoms or complaints with the subjects, and assessing their appearance. To evaluate the effectiveness of the product on restoring fullness to the cheek area, a 6-point scale ranging from 0 to 5 was used.
What did the clinical study show?
JUVÉDERM VOLUMA® XC injectable gel was found to effectively correct cheek shape and fullness.
• 86% of subjects had at least a 1-point improvement in their cheek fullness 6 months after treatment
• Subjects rated themselves as looking an average of 5 years younger 6 months after their last treatment
• More than 75% of subjects reported an improvement in their overall satisfaction with their facial appearance at 2 years after their last treatment
The clinical study showed that JUVÉDERM VOLUMA® XC injectable gel lasts up to 2 years in the majority of subjects.
What side effects were seen in the clinical study?
Most subjects in the clinical study experienced tenderness, swelling, firmness, and/or lumps/bumps at the injection site, as reported in their 30-day daily diary. These side effects were usually moderate in severity, did not require treatment, and generally lasted 2 to 4 weeks. Based on the clinical study, the likelihood of experiencing side effects after initial treatment with JUVÉDERM VOLUMA® XC is shown below in Table 1. These events were reported less often after repeat treatment.
What adverse events were seen in the clinical study?
Adverse events (any side effects to JUVÉDERM VOLUMA® XC that lasted longer than the 30-day daily diary, or side effects that occurred after 30 days) were reported over the course of the study. The most common adverse events were the same as those reported as side effects in the daily diary, such as lumps/bumps, firmness, swelling, and pain. Adverse events were seen more frequently in subjects who received a large volume of product and subjects who were older. Rarely, adverse events occurred weeks to months after the injection procedure.
The 2nd Study Presented
The second study was carried out by three well known South Korean researchers: Kwak TI, Oh MM, Kim JJ, and Moon DG. It is under the name of: The Effects of Penile Girth Enhancement Using Injectable Hyaluronic Acid Gel, a Filler.
The authors state that despite the debates on penile girth enhancement (PGE), demands for enhancement are increasing. Recently, various fillers have been widely used for soft tissue augmentation with proven efficacy and safety. Thus, they have decided to do a research in order to identify the feasibility and efficacy of PGE by injection of filler.
In the study, from April 2006 to February 2008, 50 patients were enrolled and 41 patients were followed until 18 months after PGE. Changes in penile girth at midshaft were measured by tapeline at 1 and 18 months. Patient's visual estimation of residual volume (Gr 0–4), patient's satisfaction (Gr 0–4), and any adverse reactions were also evaluated.
According to the authors, mean injected volume was 20.56 cc (18–22). Compared with basal girth of 7.48 ± 0.35 cm, maximal circumference was significantly increased to 11.41 ± 0.34 cm at 1 month (P < 0.0001) and maintained as 11.26 ± 0.33 cm until 18 months. In patient's visual estimation, two patients complained the decrease as Gr 3 with focal depression at 1 month. At 18 months, all patients answered as Gr 4 without asymmetry. Patient's and partner's satisfaction score was 3.71 ± 0.46 and 3.65 ± 0.48 at 1 month and 3.34 ± 0.53 and 3.38 ± 0.49 at 18 months. There were no inflammatory signs or serious adverse reactions in all cases.
In conclusion, it was summed up that considering the property of material, methods, and follow‐up results of 18 months, PGE using filler is a very effective and safe technique for penile augmentation.
There have been many more studies about hyaluronic acid injections for penile enhancement carried out proving such a treatment's safety and approval by many scientific and medical representatives.
"My experience about hyaluronic acid fillers is extremely positive and I strongly suggest hyaluronic acid injections for penile girth enhancement, as a well researched, safe and non-surgical option to achieve desirable penile girth, that has been also approved by many researches." - Dr Greta Peciulyte
References:
- information provided by Allergan: © 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners. Patented. See: www.allergan.com/products/patent_notices. www.juvederm.com 05/2016 16205.
- Kwak TI, Oh MM, Kim JJ, and Moon DG. The effects of penile girth enhancement using injectable hyaluronic acid gel, a filler. J Sex Med 2011;8(12) :3407-3413.