Injectable Gel for Acne Scars

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{2 4 5 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• ELAPR002f Injectable Gel (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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. China pubmed.ncbi.nlm.nih.gov

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

3. Croatia pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. [2020]

7. United States 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. [2023]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The role of fillers in the management of acne scars. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Tretinoin-iontophoresis in atrophic acne scars. [2019]