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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 in adults. It is being developed by AbbVie Inc. (ABBV) and is currently in clinical trials for these dermatological indications.
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 dermatological uses.
ELAPR002f Injectable is in Phase 2 and Phase 3 clinical trials. It is an investigational product and has not been approved by regulatory authorities. Studies are ongoing to assess its safety and effectiveness for treating atrophic acne scars and improving skin quality.
ELAPR002f Injectable has been studied in several clinical trials. NCT05995340 evaluated the gel in 157 participants with atrophic acne scars in Canada and Germany. NCT06151535 assessed skin quality improvement in 30 adults in Italy. NCT07207369 is currently recruiting 395 participants with acne scars in the United States.
ELAPR002f Injectable is the injectable formulation of the product referred to as ELAPR002f. The clinical trials listed for this asset use the name ELAPR002f Injectable Gel, indicating it is a gel formulation intended for injection.