Injectable gel treatment for atrophic acne scars
An International, Multicenter, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
This study is testing a new injectable gel to see if it can improve the appearance of atrophic acne scars in adults and help them feel better about their skin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 12 sites (Edmonton, Alberta and 11 other locations) |
| Trial ID | NCT05995340 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of ELAPR002f, an injectable gel designed to treat atrophic acne scars in adults. Participants will be randomly assigned to receive either the ELAPR002f gel or a saline active control. The study aims to assess improvements in scar appearance and overall quality of life for those suffering from moderate to severe atrophic acne scarring. The trial will involve approximately 156 adult participants and will focus on specific scar types and severity levels.
Who should consider this trial
Good fit: Ideal candidates are adults in good health with moderate to severe atrophic acne scars seeking improvement.
Not a fit: Patients with active facial acne, certain inflammatory skin conditions, or predominantly ice pick scars may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the appearance of atrophic acne scars, enhancing patients' self-esteem and quality of life.
How similar studies have performed: Other studies have shown promise with similar injectable treatments for acne scars, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Edmonton, Alberta and 11 other locations
- Alberta DermaSurgery Centre /ID# 243168 — Edmonton, Alberta, Canada (Recruiting)
- Humphrey & Beleznay Cosmetic Dermatology /ID# 266634 — Vancouver, British Columbia, Canada (Recruiting)
- Pacific Derm /ID# 227467 — Vancouver, British Columbia, Canada (Recruiting)
- Dermetics Cosmetic Dermatology /ID# 227469 — Burlington, Ontario, Canada (Recruiting)
- The Centre for Clinical Trials /ID# 233841 — Oakville, Ontario, Canada (Recruiting)
- The Center For Dermatology /ID# 227470 — Richmond Hill, Ontario, Canada (Recruiting)
- Bertucci MedSpa Inc. /ID# 227468 — Woodbridge, Ontario, Canada (Recruiting)
- Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566 — Blankenfelde-Mahlow, Brandenburg, Germany (Recruiting)
- Rosenpark Research /ID# 227471 — Darmstadt, Hessen, Germany (Recruiting)
- Privatpraxis Dr. Hilton & Partner /ID# 227472 — Duesseldorf, Nordrhein-Westfalen, Germany (Recruiting)
- Hautok and Hautok-cosmetics /ID# 227474 — Muenchen, Saarland, Germany (Recruiting)
- MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 227475 — Oberursel, Saarland, Germany (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.