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Injectable Gel

ELAPR002f Injectable Gel for Atrophic Acne Scars

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 5 rolling or boxcar-type acne scars in total within the predefined assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 420
Awards & highlights

Study Summary

This trial is testing a new injectable gel for treating atrophic acne scars. 156 adult participants will receive 3 treatments over 2 months and be monitored up to 12 months.

Who is the study for?
This trial is for adults in good health who want to improve moderate to severe atrophic acne scars on both cheeks. They must not have an active COVID-19 infection and should have at least 5 rolling or boxcar-type scars in areas of otherwise healthy skin.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of ELAPR002f injectable gel versus a saline control in treating facial atrophic acne scars. Participants will be randomly assigned to one of these treatments, with a higher chance of receiving the gel.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness, swelling, pain, bruising, bleeding or itching. There might also be general discomfort associated with intradermal injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 5 rolling or boxcar acne scars on my cheek.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 420
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 420 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Procedure Pain
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements
+6 more
Secondary outcome measures
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Saline ControlExperimental Treatment1 Intervention
Participants will receive 3 treatments of Saline Control into the cheek area on each side of the face.
Group II: ELAPR002f Injectable GelExperimental Treatment1 Intervention
Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,234 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,953 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for the trial?

"As confirmed on clinicaltrials.gov, this medical trial is presently recruiting participants. It was initially posted to the platform November 21st 2023 and has been updated most recently December 12th of that same year."

Answered by AI

How many subjects have volunteered in this research project?

"Affirmative, according to clinicaltrials.gov this research program is actively recruiting participants. It was first unveiled on November 21st 2023 and most recently updated on December 12th 2023. This trial requires 156 volunteers located in 3 different medical centres."

Answered by AI

What is the aim of this experiment?

"This clinical trial will take up to 420 days and its primary objective is to analyze the clinically relevant changes in laboratory parameters from baseline. The secondary objectives are measuring change on ACNE-Q - Appearance-Related Distress questionnaire; noting percent change in acne scar volume, as measured with 3D camera imaging software; and calculating percentage of participants who achieve a 20% reduction in their acne scar area, also calculated using 3D camera imaging software."

Answered by AI

What potential risks are posed by ELAPR002f Injectable Gel?

"Our experts at Power assigned ELAPR002f Injectable Gel a rating of 3, as the phase 3 trial has produced concrete evidence supporting it's efficacy and a high degree of safety."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Tried everything and nothing works.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars
2023. "ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995340.
All > Scar > Acne Scar
~104 spots leftby Aug 2025
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