Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for the Improvement of Skin Quality in Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Skin Quality Deficit
Eligibility:
All Genders
30-60 years
Phase:
PHASE2
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, resul...
Eligibility Criteria
Inclusion
- Participants in general good health, in the opinion of the investigator, with no known active COVID-19 infection, seeking improvement of facial skin quality.
- Moderate or severe (symmetric grade 2 or 3 on the Allergan Fine Lines Scale \[AFLS\] and Allergan Cheek Smoothness Scale \[ACSS\]) fine lines and cheek smoothness scores on both cheeks based on investigator's live assessment.
- Each cheek is amenable to at least a 1 point improvement on the AFLS and ACSS.
Exclusion
- Current cutaneous or mucosal inflammatory or infectious processes (eg, herpes), rosacea, abscess, an unhealed wound, active acne, or a cancerous or precancerous lesion, on the face or behind the ears.
- History of pigmentation disorders or current pigmentation disorder on the face or behind the ears.
- Active smoker.
- Currently using topical retinoids, or have used topical retinoids in the past 60 days (2 months) on the face or behind the ears.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06151535
Start Date
December 19 2023
End Date
February 24 2025
Last Update
March 5 2025
Active Locations (1)
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1
CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370
Verona, Italy, 37134