ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Atrophic Acne Scars

Treatments: Other: Saline Active Control; Device: ELAPR002f Injectable Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05995340

CIV-23-03-042622 (Other Identifier)

2015-702-008

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 2 patient groups

ELAPR002f Injectable Gel

Experimental group

Description:

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

Treatment:

Device: ELAPR002f Injectable Gel

Saline Active Control

Other group

Description:

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

Treatment:

Other: Saline Active Control