Acne
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Acne
2015-702-008 Enrolling

Atrophic Acne Scars Research Trial (60 Weeks)


Treatment: Injection Age: 18 Years


Adults aged 18 years and older with a clinical diagnosis of atrophic acne scars (AAS) are needed for this clinical research trial.  Eligible participants must have moderate to severe AAS with at least 5 rolling or boxcar-type scars on their cheeks, and not be active smokers, have a history of asthma, or an autoimmune disease.

All participants will receive investigational intradermal injection (ID) treatments (active study drug) or saline control during the treatment period.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses will be provided.

Study participation will last roughly 60 weeks and involve about 12 visits to the study centre.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Mani Raman

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: April 07, 2024

Official 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

ClinicalTrials.gov ID

NCT05995340

Sponsor

AbbVie

Study Description

  • Brief Summary:

    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 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 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.

  • Condition or Disease:

    Atrophic Acne Scars

  • Intervention/Treatment:

    Device: ELAPR002f Injectable Gel
    Other: Saline Control
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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 active/ongoing acne lesions 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 asthma.
Known hypersensitivity to the constituents of the device.
Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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Acne

Acne affects more than 85% of teenagers and may frequently continue into adulthood. The cause of acne is unknown, but may include hormones, genetic factors, or stress. While not a life-threatening condition, acne can cause both physical discomfort and a psychological impact regardless of age. Learn More
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