ELAPR002f Injectable Gel for Atrophic Acne Scars
ELAPR002f Injectable Gel
+ Saline Control
Treatment Study
Summary
Study start date: October 24, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on evaluating the safety and effectiveness of an injectable gel called ELAPR002f, which is being developed to treat atrophic acne scars. These types of scars are indented marks left behind after acne heals, and they can significantly affect a person's quality of life by impacting self-esteem and causing embarrassment. The study aims to provide a treatment that fills in these scars, potentially improving the appearance of the skin and enhancing the quality of life for adults who suffer from moderate to severe atrophic acne scars. Participants in this study will receive three treatments over two months. The treatment involves intradermal injections, meaning the gel is injected directly into the skin. There are two groups in the study: one group receives the ELAPR002f gel, and the other may receive a saline solution as a control. Participants are randomly assigned to these groups, with a one in four chance of receiving the control treatment. The study will take place at about 25 sites across the United States, and it involves regular visits to a clinic or hospital for medical assessments, including blood tests and questionnaires, to monitor any side effects and evaluate the effectiveness of the treatment. Participants should be aware that this trial may require more time and effort compared to their usual care.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.395 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Advanced Research Associates - Glendale /ID# 254961
Glendale, United StatesOpen Advanced Research Associates - Glendale /ID# 254961 in Google MapsMarcus Facial Plastic Surgery /ID# 275880
Redondo Beach, United StatesPacific Clinical Innovations /ID# 256185
Vista, United StatesDMR Research PLLC /ID# 256199
Westport, United States