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Clinical Trial

ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

NCT: NCT05995340 · ACTIVE_NOT_RECRUITING

NCT IDNCT05995340
StatusACTIVE_NOT_RECRUITING
Start Date2023-11-21
Completion2026-07

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 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.

Frequently Asked Questions

What is ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars?

ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars is a clinical trial registered under NCT05995340. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05995340?

The current status of NCT05995340 (ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars) is: ACTIVE_NOT_RECRUITING.

When did ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars start?

ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars started on 2023-11-21.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.