Healthy AdultsNCT04206293
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
A study testing Juvederm® VOLITE in people with Healthy Adults and Skin Enhancement, run by Allergan at 1 site in Poland.
Trial summary
To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Skin Enhancement
- What is being tested?
- Juvederm® VOLITE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 sitePoland
- Study dates
- 8 Oct 2019to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Participants with Fitzpatrick skin type II or III
- Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus [HIV], B and C hepatitis analysis at screening)
- Written informed consent and data privacy consent obtained
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study
- Participant participating to another research on human beings or being in an exclusion period for a previous study
- Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study
- Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start
- Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)
- Participant having received injections of permanent or semi-permanent filling products in the studied zones
Show all 9Show fewer
- Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study
- Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after
- Participant under immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open-Label Study, to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.
- Conditions
- Healthy Adults, Skin Enhancement
- Being tested
- Juvederm® VOLITE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvederm® VOLITEDevice
1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram).
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® VOLITE | Experimental | Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 centimeter (cm) x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 milliliter (mL) was injected on the zone treated. Receives: Device: Juvederm® VOLITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Hydration as Measured by Corneometer®
Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ®
Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®
The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.
Measured: First dose of study treatment to end of the study (Up to 9 months)
Secondary outcomes (15)
Change From Baseline in Skin Elasticity as Measured by Elastimeter®
Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter. Higher values of ISE indicate higher skin elasticity. A positive change from Baseline indicates increased skin elasticity. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Thickness as Measured by Skin Scanner®
Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Density as Measured by Skin Scanner®
Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Roughness as Measured by Vivosight OCT®
Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased skin roughness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased epidermal thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®
OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased plexus depth. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased vessel diameter. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Vessel Density as Measured by Vivosight OCT®
Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. A positive change from Baseline indicates increased vessel density. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in 300 μm Density as Measured by Vivosight OCT®
300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased 300 μm density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Brightness Index as Measured by Glossymeter®
Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in "Glossymeter Units". Values were obtained from a mixed ANOVA model. Higher glossymeter values indicate higher skin brightness. A positive change from Baseline indicates increased skin brightness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Colour as Measured by Spectrophotometer®
Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L*: for clarity (from dark to light) a*: for the green-to-red spectrum b*: for the blue-to-yellow spectrum; a* and b* are chrominance parameters, L* is a luminance parameter. Higher values of a*, b*and L* indicates 'skin more red', 'skin more yellow' and 'skin clearer'. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®
Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L*) and the melanin parameter (b*). 3 measurements were done on the same zone and the average values were calculated. Values were obtained from a mixed ANOVA model and expressed in degree (°). Higher values of ITA° indicates 'skin less pigmented'. A positive change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Change From Baseline in Skin Melanin Index as Measured by Mexameter®
Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value for each parameter in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Measured: Baseline (D0) to D28 and D84
Number of Participants With Injection Site Reactions (ISR)
ISRs are reactions that occur after injection of the study drug. The following ISRs: Redness/Erythema, Pain/Tenderness, Induration, Swelling/Oedema, Lumps/Bumps, Bruising/Hematoma, Itching, Discoloration/Pigmentation were reported as None, Mild, Moderate or Severe. Only those categories reported for at least 1 participant are reported.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start8 Oct 2019
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Hee, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206293
- Sponsor's protocol ID
- CMO-MA-FAS-0617
- Status last verified
- Jul 2021
- First submitted
- 18 Dec 2019
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label Study, to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04206293
- Acronym / sponsor ID
- CMO-MA-FAS-0617
- Conditions
- Healthy Adults, Skin Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® VOLITE | Experimental | Device: Juvederm® VOLITEParticipants received Juvéderm® VOLITE, intradermal injection on a zone of 8 centimeter (cm) x 4 cm (32 cm^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 milliliter (mL) was injected on the zone treated. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy participants
- Participants with Fitzpatrick skin type II or III
- Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus [HIV], B and C hepatitis analysis at screening)
- Written informed consent and data privacy consent obtained
Key exclusion criteria (9 listed)
- Pregnant or nursing woman or planning a pregnancy during the study
- Participant participating to another research on human beings or being in an exclusion period for a previous study
- Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study
- Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start
- Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)
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 |
|---|---|---|
| Juvederm® VOLITE1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram). | Device | Juvéderm® VOLITE |
Primary outcome
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Time frame: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Time frame: Baseline (D0) to D28 and D84
Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Skin Hydration as Measured by Corneometer®
Time frame: Baseline (D0) to D28 and D84
Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ®
Time frame: Baseline (D0) to D28 and D84
Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®
Time frame: Baseline (D0) to D28 and D84
The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
Time frame: First dose of study treatment to end of the study (Up to 9 months)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.
15 secondary outcomes
Change From Baseline in Skin Elasticity as Measured by Elastimeter®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Thickness as Measured by Skin Scanner®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Density as Measured by Skin Scanner®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Roughness as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Vessel Density as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in 300 μm Density as Measured by Vivosight OCT®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Brightness Index as Measured by Glossymeter®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Colour as Measured by Spectrophotometer®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®
Time frame: Baseline (D0) to D28 and D84
Change From Baseline in Skin Melanin Index as Measured by Mexameter®
Time frame: Baseline (D0) to D28 and D84
Number of Participants With Injection Site Reactions (ISR)
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charlie Hee study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvederm® VOLITE in people with Healthy Adults and Skin Enhancement, run by Allergan at 1 site in Poland.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm (time frame: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2021.