Approval Probability
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ELAPR002f Injectable, Saline Control · 1 trial · 1 indication
The acne scar area is calculated from 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the treating investigator (TI).
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.
Incidence of ISRs/systemic responses as recorded by e-diary. ISRs are defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration (not redness or bruising).
Vital sign parameters include body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.
Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.
Participants will assess procedure pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) after each of the 3 treatment sessions.
Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.
Number of participants with any acute cognitive changes or any change in confrontational visual fields, ocular motility, or a worsening (1-line change or more) on the Snellen visual acuity assessment.
Participants who are suspected of having a hypersensitivity reaction or have a hypersensitivity reaction to the volar forearm injection site will require a punch biopsy of the volar forearm injection site.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Open-Label ELAPR002f Injectable Gel | EXPERIMENTAL | Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
| Cohort 2: ELAPR002f Injectable Gel | EXPERIMENTAL | Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
| Cohort 2: Saline Control | EXPERIMENTAL | Participants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
| Name | Type | Description |
|---|---|---|
| ELAPR002f Injectable Gel | DEVICE | Intradermal Injections |
| Saline Control | DEVICE | Intradermal Injections |
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...
ELAPR002f Injectable is an investigational injectable gel being studied for the treatment of atrophic acne scars and for the improvement of skin quality deficit in adults. It is in clinical development for dermatology indications, including acne scars and skin quality issues.
ELAPR002f Injectable is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and effectiveness of this injectable gel for dermatology applications.
ELAPR002f Injectable is in Phase 2 and Phase 3 clinical trials. One Phase 2 study has been completed, and two Phase 3 studies are listed, one completed and one currently recruiting participants. It remains investigational and has not been approved by regulatory authorities.
ELAPR002f Injectable has been studied in three clinical trials. NCT05995340 is a completed Phase 3 study in atrophic acne scars with 157 participants in Canada and Germany. NCT06151535 is a completed Phase 2 study in skin quality deficit with 30 participants in Italy. NCT07207369 is a recruiting Phase 3 study in acne scars with 395 participants in the United States.
ELAPR002f Injectable is the name used in clinical trials for this product. The drug is consistently referred to as ELAPR002f Injectable in the study records, and no alternative names have been identified in the available information.