A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Official title

A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Overview

Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f injectable gel is an investigational device being developed for the treatment of facial atrophic acne scars. There are 2 cohorts in this study. In Cohort 1, all participants will receive ELAPR002f injectable gel. In Cohort 2, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States. Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 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.

Interventions

• Device ELAPR002f Injectable Gel
  Intradermal Injections
• Device Saline Control
  Intradermal Injections

Primary outcome measures

• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area [Time frame: Baseline to Day 181]
• Number of Participants with Adverse Events [Time frame: Up to Day 420]
• Number of Participants with Presence of Binding Antibodies [Time frame: Up to Day 420]
• Number of Participants with Injection Site Responses (ISRs) and Systemic Responses [Time frame: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [Time frame: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [Time frame: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements [Time frame: Up to Day 420]
• Change from Baseline Procedure Pain [Time frame: Up to Day 420]
• Number of Participants with a Positive Skin Test [Time frame: Up to Day 420]
• Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion [Time frame: Up to Day 420]

Secondary outcome measures (7)

• Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire [Time frame: Up to Day 420]
• Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress [Time frame: Up to Day 420]
• Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score [Time frame: Up to Day 420]
• Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator [Time frame: Up to Day 420]
• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area [Time frame: Up to Day 420]
• Percent Change from Baseline in Acne Scar Area [Time frame: Up to Day 420]
• Percent Change from Baseline in Acne Scar Volume [Time frame: Up to Day 420]

Eligibility criteria

Inclusion criteria

• Participants in general good health, and seeking improvement of atrophic acne scars.
• Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan Acne Scar Improvement Scale \[ASIS\]) on each cheek based on evaluating investigator (EI) 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 4 cm × 4 cm assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator (TI).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 10 centers

• Advanced Research Associates - Glendale /ID# 254961 — Glendale
• Marcus Facial Plastic Surgery /ID# 275880 — Redondo Beach
• Pacific Clinical Innovations /ID# 256185 — Vista
• DMR Research PLLC /ID# 256199 — Westport
• Hamilton Research, LLC /ID# 256925 — Alpharetta
• Aesthetic Center at Woodholme /ID# 256197 — Baltimore
• The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182 — Mount Kisco
• Wilmington Dermatology Center /ID# 256192 — Wilmington
• … and 2 more centers

Identifiers

NCT: NCT07207369 · 2015-701-008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗