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ELAPR002f Injectable , Saline Control

Phase 3

Acne Scars | Unknown | Dermatology |AbbVie Inc.|Last Updated: Nov 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment395
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07207369A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne ScarsPHASE3 RECRUITING 395Oct 24, 2025Nov 1, 2029Nov 24, 202510 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
Baseline to Day 181

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).

Number of Participants with Adverse Events
Up to Day 420

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.

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

Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.

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. 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 420

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 420

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.

Number of Participants Needing a Histology of Volar Forearm Site Biopsy
Up to Day 420

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.

Secondary Endpoints
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
Up to Day 420
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
Up to Day 420
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score
Up to Day 420
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: Open-Label ELAPR002f Injectable GelEXPERIMENTALParticipants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Cohort 2: ELAPR002f Injectable GelEXPERIMENTALParticipants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Cohort 2: Saline ControlEXPERIMENTALParticipants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Interventions
NameTypeDescription
ELAPR002f Injectable GelDEVICEIntradermal Injections
Saline ControlDEVICEIntradermal Injections
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Eligibility Criteria
Age Range22 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07207369primaryCompletionDate: changed
LOWMay 24, 2026NCT07207369studyFirstPostDate: changed