Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-22
Brief Title:
A Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for the Improvement of Skin Quality in Adult Participants
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
An Open-label Study Evaluating the Safety and Effectiveness of Intradermal Injections of ELAPR002f Injectable Gel in the Improvement of Multiple Attributes of Skin Quality in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Elastin is a protein found in the dermis of the skin that is gradually lost with aging which impacts skin tissue and leads to reduced structural integrity hydration and elasticity of the skin resulting in loose skin and the formation of folds and wrinkles Loose skin folds and wrinkles can be treated by injecting biocompatible structures to fill the the affected area and improve elasticityhydration upon implantation The purpose of this study is to evaluate the safety and effectiveness of ELAPR002f injectable gel in adult participants for the improvement of skin quality in adults
ELAPR002f injectable gel is an investigational device being developed for the improvement of facial skin quality attributes such as fine lines elasticity and hydration Approximately 30 participants 30 to 60 years of age seeking improvement of skin quality will be enrolled
Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel to each cheek and behind 1 ear for histological assessment and will be followed up for up to 4 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 blood tests checking for side effects and completing questionnaires
ELAPR002f injectable gel is an investigational device being developed for the improvement of facial skin quality attributes such as fine lines elasticity and hydration Approximately 30 participants 30 to 60 years of age seeking improvement of skin quality will be enrolled
Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel to each cheek and behind 1 ear for histological assessment and will be followed up for up to 4 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 blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None