NCT05995340
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.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
18 Years and older.
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.
