Recent Updates
Recently added Catalysts

ELAPR002f Injectable , Saline Active Control

Phase 3

Atrophic Acne Scars | Unknown | Dermatology |AbbVie Inc.|Last Updated: Apr 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment157
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05995340ELAPR002f Injectable Gel in the Treatment of Atrophic Acne ScarsPHASE3 ACTIVE NOT_RECRUITING 157Nov 21, 2023Jul 1, 2026Apr 30, 202612 Canada, Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS)
Baseline to Day 181

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.

Number of Participants with Adverse Events
Up to Day 420

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.

Number of Participants with Presence of Binding Antibodies
Up to Day 420

Presence of binding antibodies

Number of Participants with Injection Site Responses (ISRs) and Systemic Responses
Up to Day 420

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).

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Up to Day 420

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.

Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Up to Day 420

Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.

Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements
Up to Day 420

Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.

Change from Baseline Procedure Pain
Up to Day 61

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.

Number of Participants with a Positive Skin Test
Up to Day 30

Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.

Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion
Up to Day 420

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,

Secondary Endpoints
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Scale
Up to Day 420
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress Scale
Up to Day 420
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale
Up to Day 420
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Saline Active ControlOTHERParticipants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face.
ELAPR002f Injectable GelEXPERIMENTALParticipants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face.
Interventions
NameTypeDescription
ELAPR002f Injectable GelDEVICEIntradermal Injections
Saline Active ControlOTHERIntradermal Injections
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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...

Countries:CanadaGermany
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05995340primaryCompletionDate: changed
LOWMay 24, 2026NCT05995340studyFirstPostDate: changed