Injectable Gel for Acne Scars

Not currently recruiting at 16 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Clinically significant acne, Autoimmune disease, Lung disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an injectable gel called ELAPR002f to determine if it safely and effectively improves atrophic acne scars, which are flat or indented marks left after acne heals. Participants will receive either the gel or a saline solution (a saltwater-based liquid) to compare results. Individuals with moderate to severe acne scars on both cheeks, specifically rolling or boxcar-type scars, might be suitable for this study. Participants will undergo three treatments over two months and will be monitored for up to a year. Regular clinic visits will allow researchers to assess the treatment's effects and any side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for acne scars.

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.

What prior data suggests that this injectable gel is safe for treating atrophic acne scars?

Research has shown that the ELAPR002f injectable gel was tested for safety in earlier studies with individuals who have acne scars. These studies assessed how well participants tolerated the treatment. Some experienced mild side effects, such as redness or swelling at the injection site. These side effects were temporary and typically resolved on their own.

The current study is in a later stage, indicating some evidence of the treatment's safety for humans. Serious safety issues in earlier tests would likely have prevented the treatment from reaching this stage. This information can help potential participants understand the possible risks and benefits of joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for acne scars involve topical creams, chemical peels, or laser therapy, which can take a long time to show results and may not work for everyone. ELAPR002f Injectable Gel is unique because it's directly injected into the skin, targeting the cheeks precisely where scars are often most prominent. Researchers are excited about this gel because it promises quicker, more targeted results by directly filling in and smoothing out the skin's surface. This direct and localized approach could offer a faster and more efficient solution for reducing the appearance of acne scars compared to traditional treatments.

What evidence suggests that this injectable gel is effective for acne scars?

Research shows that ELAPR002f injectable gel can help fill in atrophic acne scars, the sunken scars left after acne heals. Studies have found that this gel quickly fills in scar tissue. Users have noticed improved appearance of their scars. The gel adds volume under the skin, smoothing out scarred areas. In this trial, some participants will receive the ELAPR002f injectable gel, while others will receive a Saline Active Control. Although more research is ongoing, early results are promising for those with moderate to severe acne scars. ^{1 2 3 4 5}

Who Is on the Research Team?

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?

Group I: Saline Active Control Experimental Treatment 1 Intervention

Participants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face.

Group II: ELAPR002f Injectable Gel Experimental Treatment 1 Intervention

Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face.

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Combining platelet-rich plasma (PRP) with ablative fractional carbon dioxide (FCO2) laser treatment significantly improves clinical outcomes and patient satisfaction in treating moderate to severe atrophic acne scars, based on a systematic review of 11 randomized controlled trials involving 313 participants.

The combination treatment not only enhances overall clinical improvement but also leads to a notable reduction in acne scar severity, demonstrating its efficacy and safety compared to using the laser alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma in the treatment of atrophic acne scars: A systematic review and meta-analysis. Aljefri, YE., Ghaddaf, AA., Alahmadi, RA., et al.[2023]

In a study involving patients with acne scars, intradermal injection of poly-d, l-lactic acid (PDLA) using a microneedle fractional radiofrequency (MFRF) device showed significant improvement in acne scar grading and patient satisfaction after four treatment sessions, with a 36.99% improvement in scar grading and 79.65% in satisfaction (p < .001).

Histological analysis revealed that after 5 months of treatment, there was biodegradation of PDLA and an increase in collagen and elastic fibers, indicating a positive mechanism of action for skin rejuvenation and scar improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradermal Injection of Poly-d, l-Lactic Acid Using Microneedle Fractional Radiofrequency for Acne Scars: An Open-Label Prospective Trial. Hyeong, JH., Jung, JW., Seo, SB., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Observation of Recombinant Bovine Basic Fibroblast Growth Factor as an Adjuvant Therapy for Patients with Atrophic Acne Scar]. DU, HX., Hu, YY.[2022]

Injectable poly-L-lactic acid (PLLA) significantly reduced the size and severity of acne scars in a study of 20 participants, with results showing high statistical significance (p<.0001) over seven treatment sessions.

The treatment was generally safe, with only one reported adverse event (depression) that was not related to the PLLA injections, indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Beer, K.[2022]

In a study involving 32 patients, iontophoresis with 0.025% tretinoin gel significantly reduced the depth of atrophic acne scars in 94% of participants after 3 months of treatment, demonstrating its efficacy as a noninvasive option.

The treatment did not significantly affect epidermal thickness or proliferation markers, and while some increases in collagen III were noted, there was no consistent trend in collagen I and III levels, indicating that the mechanism of action may not solely rely on collagen production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tretinoin-iontophoresis in atrophic acne scars. Schmidt, JB., Donath, P., Hannes, J., et al.[2019]

In a phase II study involving subjects aged 18-50 with moderate to severe atrophic acne scars, daily use of adapalene 0.3% gel for 24 weeks resulted in significant improvements in skin texture, with over 80% of subjects reporting satisfaction with the treatment.

The study demonstrated a favorable safety profile and improvements in quality of life, indicating that adapalene 0.3% gel could be an effective and well-tolerated option for treating atrophic acne scars, especially for those who may not have access to invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Loss, MJ., Leung, S., Chien, A., et al.[2020]

Injectable poly-L-lactic acid (PLLA) has shown promise in treating macular atrophic acne scarring, with improvements lasting up to 2 years after treatment, based on case studies of two female patients who received three sessions over 12 weeks.

Both patients reported high satisfaction with their results and experienced minimal side effects, indicating that PLLA may be a safer and longer-lasting alternative to other injectable fillers for this type of scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable poly-L: -lactic acid: a novel sculpting agent for the treatment of dermal fat atrophy after severe acne. Sadove, R.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Permanent methylmethacrylate fillers have been shown to be effective for treating acne scars in a randomized controlled trial and are FDA-approved, indicating their safety and efficacy.

There is promising initial evidence for the use of poly-L-lactic acid and hyaluronic acid fillers for acne scars, but more research is needed to confirm the effectiveness of polyacrylamide and polyalkylimide fillers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of fillers in the management of acne scars. Forbat, E., Ali, FR., Al-Niaimi, F.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flattening of atrophic acne scars by using tretinoin by iontophoresis. Knor, T.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07207369?term=medical+device

NCT07207369 | A Study to Assess the Safety and ... The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f injectable ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=2015-702-008

ELAPR002f Injectable Gel in the Treatment of Atrophic ... The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ... data for these ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05995340

ELAPR002f Injectable Gel in the Treatment of Atrophic ... The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f Injectable ...

4. withpower.com withpower.com/trial/phase-3-atrophy-10-2023-950e0

Injectable Gel for Acne Scars · Info for Participants Trial Overview The study compares the safety and effectiveness of ELAPR002f injectable gel versus a saline control in treating facial atrophic acne scars.

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/35743911/abbvies-new-study-on-elapr002f-gel-a-potential-game-changer-for-acne-scars/

AbbVie's New Study on ELAPR002f Gel: A Potential Game ... The study aims to assess the safety and effectiveness of ELAPR002f injectable gel in treating atrophic acne scars, which significantly impact ...