Approval Probability
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ML Risk
ELAPR002f Injectable, Saline Active Control · 1 trial · 1 indication
A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks based on the ASIS, as assessed by the EI. The ASIS is a 5-grade scale used to assess acne scar improvement ranging from 1=Almost None to 5=Severe. Each side of the face is scored separately.
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved.
Presence of binding antibodies
Incidence of ISRs/systemic responses as recorded by e-diary for up to 30 consecutive days after each of the 3 treatment sessions starting on the day of injection. 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,
| Arm | Type | Description |
|---|---|---|
| Saline Active Control | OTHER | Participants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face. |
| ELAPR002f Injectable Gel | EXPERIMENTAL | Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face. |
| Name | Type | Description |
|---|---|---|
| ELAPR002f Injectable Gel | DEVICE | Intradermal Injections |
| Saline Active Control | OTHER | Intradermal Injections |
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...
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.