Clinical trial NCT04206293: A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Official title: Prospective, Open-Label Study, to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Skin Enhancement
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-12-20
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
timeFrame: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
measure: Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Hydration as Measured by Corneometer®
timeFrame: Baseline (D0) to D28 and D84
measure: 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 ®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®
timeFrame: Baseline (D0) to D28 and D84
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
timeFrame: First dose of study treatment to end of the study (Up to 9 months)
Secondary outcomes:
measure: Change From Baseline in Skin Elasticity as Measured by Elastimeter®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Thickness as Measured by Skin Scanner®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Density as Measured by Skin Scanner®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Roughness as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Vessel Density as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in 300 μm Density as Measured by Vivosight OCT®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Brightness Index as Measured by Glossymeter®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Colour as Measured by Spectrophotometer®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®
timeFrame: Baseline (D0) to D28 and D84
measure: Change From Baseline in Skin Melanin Index as Measured by Mexameter®
timeFrame: Baseline (D0) to D28 and D84
measure: Number of Participants With Injection Site Reactions (ISR)
timeFrame: Day 0
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: EuroFins Dermscan Poland
Study officials:
affiliation: Allergan
name: Charlie Hee
role: STUDY_DIRECTOR
References: