Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris

Study of a Study Vaccine for Moderate Facial Acne in Adults

Recruiting
25 years - 100 years
All
Phase N/A
2 Locations

Brief description of study

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Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches.

The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acne
  • Age: 25 years - 100 years
  • Gender: All

Inclusion Criteria:
Exclusion Criteria:

The purpose of this research study is to learn about the safety of a study vaccine for adults who have moderate acne vulgaris (acne) on the face and are otherwise healthy. The study will also look at how the immune system responds to the vaccine.

Participants will receive either the study vaccine for acne or a placebo. A placebo looks like the study medicine but does not contain any medicine. The study will test 3 different dose levels. The study team will also collect early information on changes in acne (such as the number of acne spots and acne severity), immune response to the vaccine, and possible changes in the skin microbiome (the mix of germs that normally live on the skin).

Who can participate:
Adults with moderate facial acne vulgaris may be able to participate if they:

  • Are age 18 or older
  • Have moderate acne vulgaris on the face
  • Are otherwise healthy

Updated on 27 Jul 2026. Study ID:

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