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NCT Number: NCT05995340

ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

Visit the study website https://dawnacnescarstudy.com/ACT for more information. Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. 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 Gel is an investigational device being developed for the treatment of facial atrophic acne scars. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 156 adult participants with moderate to severe atrophic acne scarring on both cheeks will be enrolled in the study in approximately 12 sites in Germany and Canada.

Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrophic Acne Scars

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alberta DermaSurgery Centre /ID# 243168, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in general good health, with no active COVID-19 infection, and seeking improvement of atrophic acne scars.
  • Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) on each cheek based on Evaluating Investigator's live assessment (both cheeks must qualify but do not need to have the same score) at the first screening visit.
  • 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.

Exclusion criteria

  • The participant has clinically significant acne on the face.
  • Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
  • The participant presents with predominantly ice pick scars.
  • History of keloid scar formation, hypertrophic scarring and/or post inflammatory hyperpigmentation or hypopigmentation.
  • History of granulomatous or connective tissue disease.
  • Diagnosed autoimmune disease (eg, Type 1 diabetes, rheumatoid arthritis, scleroderma, vitiligo).
  • Diagnosed history of lung disease.
  • Known hypersensitivity to the constituents of the device.
  • Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.

Treatment and study plan

ELAPR002f Injectable Gel

Device

Intradermal Injections

Saline Active Control

Other

Intradermal Injections

Primary outcomes

  1. Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS)

    Time frame: Baseline to Day 181

    A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks based on the ASIS, as assessed by the EI. The ASIS is a 5-grade scale used to assess acne scar improvement ranging from 1=Almost None to 5=Severe. Each side of the face is scored separately.

  2. Number of Participants with Adverse Events

    Time frame: Up to Day 420

    An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved.

  3. Number of Participants with Presence of Binding Antibodies

    Time frame: Up to Day 420

    Presence of binding antibodies

  4. Number of Participants with Injection Site Responses (ISRs) and Systemic Responses

    Time frame: Up to Day 420

    Incidence of ISRs/systemic responses as recorded by e-diary for up to 30 consecutive days after each of the 3 treatment sessions starting on the day of injection. ISRs are defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration (not redness or bruising).

  5. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

    Time frame: 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.

  6. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

    Time frame: Up to Day 420

    Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.

  7. Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements

    Time frame: Up to Day 420

    Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.

  8. Change from Baseline Procedure Pain

    Time frame: Up to Day 61

    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.

  9. Number of Participants with a Positive Skin Test

    Time frame: Up to Day 30

    Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.

  10. Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion

    Time frame: 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,

Secondary outcomes

  1. Change from Baseline on the Overall Score of ACNE-Q Acne Scars Scale

    Time frame: Up to Day 420

    The ACNE-Q Acne Scars scale includes 10 questions that ask how much the participant is bothered by their acne scars on a 4-point scale ranging from 1=Not at all to 4=Very Much.

  2. Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress Scale

    Time frame: Up to Day 420

    ACNE-Q - Appearance-Related Distress scale includes 10 questions that ask about how the participants describe themselves on a 4-point scale ranging from 1=Never to 4=Always.

  3. Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale

    Time frame: Up to Day 420

    FACE-Q Satisfaction With Skin scale questionnaire includes 12 questions that ask how much the participants are satisfied or dissatisfied with their facial skin on a 4-point scale ranging from 1=Very Dissatisfied to 4=Very Satisfied.

  4. Percentage of Participants Achieving "Responder" Status Based on the ASIS

    Time frame: Up to Day 420

    A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks based on the ASIS, as assessed by the EI. The ASIS is a 5-grade scale used to assess acne scar improvement ranging from 1=Almost None to 5=Severe. Each side of the face is scored separately.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An International, Multicenter, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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