157 Participants Needed

Injectable Gel for Acne Scars

Recruiting at 13 trial locations
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new gel called ELAPR002f to help fill in and smooth out indented acne scars on the face. It targets adults with noticeable acne scars who haven't had success with other treatments. The gel works by filling in the scarred areas to make the skin look smoother. Participants will receive multiple treatments and be monitored for an extended period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the injectable gel for acne scars safe for humans?

The injectable poly-L-lactic acid (PLLA) gel has been used safely in humans for treating acne scars, with minimal side effects like swelling and redness, and no serious adverse events reported in the studies.12345

How does the treatment ELAPR002f Injectable Gel differ from other treatments for acne scars?

ELAPR002f Injectable Gel is unique because it is an injectable treatment specifically designed to enhance dermal volume by promoting the body's own collagen production, potentially offering longer-lasting results compared to other fillers that may have shorter durations of effect.25678

What data supports the effectiveness of the treatment ELAPR002f Injectable Gel for acne scars?

Research on similar treatments, like injectable poly-L-lactic acid (PLLA), shows that they can improve acne scars by boosting collagen production, with effects lasting up to 2 years. Patients reported satisfaction with minimal side effects, suggesting that ELAPR002f Injectable Gel might offer similar benefits.258910

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am healthy, COVID-19 free, and want to treat my acne scars.
I have at least 5 rolling or boxcar acne scars on my cheek.
I have moderate to severe acne scarring on both cheeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control

8 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ELAPR002f Injectable Gel
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Saline Active ControlExperimental Treatment1 Intervention
Group II: ELAPR002f Injectable GelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study involving 30 patients with atrophic acne scars, treatment with nanofat and platelet-rich plasma (PRP) significantly improved subcutaneous tissue thickness, indicating effective scar improvement.
Combining nanofat and PRP with fractional CO2 laser resurfacing did not show a significant difference in outcomes compared to using them alone, suggesting that both methods are effective for treating acne scars without a clear advantage of one over the other.
Comparative Study Using Autologous Fat Grafts Plus Platelet-Rich Plasma With or Without Fractional CO2 Laser Resurfacing in Treatment of Acne Scars: Analysis of Outcomes and Satisfaction With FACE-Q.Tenna, S., Cogliandro, A., Barone, M., et al.[2022]
In a study involving 120 patients with atrophic acne scars, the use of recombinant bovine basic fibroblast growth factor gel as an adjuvant therapy alongside CO2 lattice laser treatment significantly improved scar alleviation and reduced inflammatory cytokine levels compared to a control group using erythromycin ointment.
The test group experienced a higher total effective rate and fewer adverse reactions, along with quicker recovery indicators such as shorter erythema duration and earlier scab formation, demonstrating both efficacy and safety of the treatment.
[Clinical Observation of Recombinant Bovine Basic Fibroblast Growth Factor as an Adjuvant Therapy for Patients with Atrophic Acne Scar].DU, HX., Hu, YY.[2022]
A noninvasive treatment using 0.05% tretinoin gel applied through iontophoresis was clinically effective in reducing atrophic acne scars in 79% of the 38 patients studied over an average of 3.5 months.
The treatment showed better results for younger and superficial scars, and while it had mild side effects like retinoid dermatitis and occasional acne flare-ups, patients generally accepted the therapy well, suggesting it could be a viable alternative to invasive methods.
Flattening of atrophic acne scars by using tretinoin by iontophoresis.Knor, T.[2013]

Citations

Comparative Study Using Autologous Fat Grafts Plus Platelet-Rich Plasma With or Without Fractional CO2 Laser Resurfacing in Treatment of Acne Scars: Analysis of Outcomes and Satisfaction With FACE-Q. [2022]
[Clinical Observation of Recombinant Bovine Basic Fibroblast Growth Factor as an Adjuvant Therapy for Patients with Atrophic Acne Scar]. [2022]
Flattening of atrophic acne scars by using tretinoin by iontophoresis. [2013]
Injectable poly-L: -lactic acid: a novel sculpting agent for the treatment of dermal fat atrophy after severe acne. [2018]
Intradermal Injection of Poly-d, l-Lactic Acid Using Microneedle Fractional Radiofrequency for Acne Scars: An Open-Label Prospective Trial. [2022]
Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. [2020]
Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma in the treatment of atrophic acne scars: A systematic review and meta-analysis. [2023]
A single-center, open-label study on the use of injectable poly-L-lactic acid for the treatment of moderate to severe scarring from acne or varicella. [2022]
The role of fillers in the management of acne scars. [2019]
Tretinoin-iontophoresis in atrophic acne scars. [2019]
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