Acne Clinical Trial
Official title:
A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US.
Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at three different dose levels in adults aged 18 to 45 years with moderate to severe acne. The study is designed to assess the safety profile and efficacy (also long-term) of the vaccine candidate, select the dose for the further clinical development steps and to describe the immunogenicity profile of the vaccine. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05097157 -
Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
|
N/A | |
| Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT04806594 -
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
|
N/A | |
| Recruiting |
NCT03465150 -
Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
|
||
| Completed |
NCT02250859 -
A Pharmacokinetic Study of Minocycline in Male and Female Volunteers
|
Phase 1 | |
| Terminated |
NCT01193764 -
Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
|
N/A | |
| Completed |
NCT01206348 -
Combination Treatment for Moderate to Severe Acne
|
Phase 4 | |
| Completed |
NCT00725439 -
An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
|
Phase 2 | |
| Completed |
NCT05640388 -
Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
|
||
| Completed |
NCT04873089 -
Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
|
||
| Recruiting |
NCT05941065 -
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
|
N/A | |
| Recruiting |
NCT06120452 -
A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation
|
N/A | |
| Completed |
NCT04300010 -
Blue Light Therapy of C. Acnes
|
Phase 4 | |
| Recruiting |
NCT06202274 -
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
|
N/A | |
| Completed |
NCT04559022 -
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
|
N/A | |
| Terminated |
NCT02431494 -
Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris
|
N/A | |
| Completed |
NCT05469880 -
Efficacy and Tolerance of Formula 609613 37 in Acneic Patients
|
N/A | |
| Completed |
NCT02944461 -
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
|
Phase 4 | |
| Completed |
NCT01951417 -
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
|
Phase 4 | |
| Completed |
NCT01701024 -
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
|
Phase 3 |