Status:
ACTIVE_NOT_RECRUITING
ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars
Lead Sponsor:
AbbVie
Conditions:
Atrophic Acne Scars
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Visit the study website https://dawnacnescarstudy.com/ACT for more information. Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal heali...
Eligibility Criteria
Inclusion
- Participants in general good health, with no active COVID-19 infection, and seeking improvement of atrophic acne scars.
- Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) on each cheek based on Evaluating Investigator's live assessment (both cheeks must qualify but do not need to have the same score) at the first screening visit.
- At least 5 rolling or boxcar-type acne scars in total within the predefined assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator.
Exclusion
- The participant has clinically significant acne on the face.
- Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
- The participant presents with predominantly ice pick scars.
- History of keloid scar formation, hypertrophic scarring and/or post inflammatory hyperpigmentation or hypopigmentation.
- History of granulomatous or connective tissue disease.
- Diagnosed autoimmune disease (eg, Type 1 diabetes, rheumatoid arthritis, scleroderma, vitiligo).
- Diagnosed history of lung disease.
- Known hypersensitivity to the constituents of the device.
- Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT05995340
Start Date
November 21 2023
End Date
August 1 2026
Last Update
June 6 2025
Active Locations (12)
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1
Alberta DermaSurgery Centre /ID# 243168
Edmonton, Alberta, Canada, T6G 1C3
2
Humphrey & Beleznay Cosmetic Dermatology /ID# 266634
Vancouver, British Columbia, Canada, V5Z 4E1
3
Pacific Derm /ID# 227467
Vancouver, British Columbia, Canada, V6H 4E1
4
Dermetics Cosmetic Dermatology /ID# 227469
Burlington, Ontario, Canada, L7N 3N2