Neck Lines
Conditions
Brief summary
The cumulative effects of aging, weight change, ergonomics (i.e., "tech neck"), and environmental exposures (i.e., ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked hyaluronic acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin smoothness. The purpose of this study is to assess safety and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. VOLITE XC is an investigational product intended to reduce horizontal neck lines for improvement of neck appearance. Participants are placed in 1 of 2 groups, called treatment arms. Participation will be randomized in a 2:1 ratio in treatment and control arms. Up to 212 adult participants with moderate or severe transverse neck lines will be enrolled in the study at up to 20 sites. Participants in the treatment group will receive VOLITE XC at Day 1 and be followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and be followed for 6 Months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
Interventions
DEVICEVOLITE XC
Intradermal Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection. * Participants seeking improvement of transverse neck lines. * Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) based on EI live assessment.
Exclusion criteria
* Neck deformity or significant skin laxity with severe redundant folds. * Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area. * Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck. * Tendency to develop hypertrophic scarring. * History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area. * Permanent soft tissue fillers in the neck area. * Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment. * HA fillers or autologous fat in the neck area within 12 months before enrollment. * Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment. * Botulinum toxin in the neck area within 6 months before enrollment. * Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment. * Neck surgeries and procedures. * Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments. * Pregnant, nursing or planning a pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving "Responder" Status Based on Evaluating Investigator's (EI) Live Assessment of Transverse Neck Lines Using the Allergan Transverse Neck Lines Scale (ATNLS) | Month 1 | ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme). A "responder" is a participant with at least 1-grade improvement on the ATNLS. |
| Number of Participants With Treatment-Emergent Adverse Events | Baseline to end of study (up to 14 Months) | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving "Responder" Status for EI's Assessment of Global Aesthetic Improvement on the Neck Using the Global Aesthetic Improvement Scale (GAIS) | Month 1 | GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS. |
| Change From Baseline to Month 1 in the Rasch-transformed Scores on FACE-Q Appraisal of the Neck Questionnaire | Baseline to Month 1 | FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of the Neck questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100. A higher score indicates greater satisfaction with facial appearance. |
| Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement on the Neck Using GAIS | Month 1 | A "responder" is a participant who shows improvement in the overall aesthetic assessment in the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved; -2=Much Worse). |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Participant flow
Recruitment details
A total of 159 adult participants with moderate or severe transverse neck lines were randomly assigned; 105 in the treatment group and 54 in the control group. The ITT and safety populations included 159 participants each.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.3 Years STANDARD_DEVIATION 8.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 124 Participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 54 | 0 / 43 | 0 / 46 |
| other Total, other adverse events | 21 / 105 | 0 / 54 | 6 / 43 | 3 / 46 |
| serious Total, serious adverse events | 5 / 105 | 0 / 54 | 2 / 43 | 1 / 46 |
Outcome results
None listed