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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CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370

Verona, Italy, 37134