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Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis

Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid® Gel (Hydrogen Peroxide and Hyaluronic Acid) in the Treatment of Acne Vulgaris and Folliculitis.

NCT05345093•BMG Pharma

View on ClinicalTrials.gov

Summary

The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, and folliculitis, will Ialuxid® Gel (hydrogen peroxide, hyaluronic acid and glycine) improve the course of the disease, resulting in a decrease of the total number of lesions, results observed after 4 and 8 weeks after the beginning of the treatment?

Detailed Description

Ialuxid® Gel is a non-antibiotic treatment in gel indicated for use in a variety of skin conditions, and also in case of infection. Its principal ingredient is Ialuvance™ Complex, a proprietary association of hydrogen peroxide, hyaluronic acid, and glycine.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women aged ≥ 18 and ≤ 45 years.
•2. Patients diagnosed with acne vulgaris, and folliculitis.
•a. Only for patients with acne vulgaris: mild to moderate Global Acne Grading Scale score (≤ 30).
•3. Patients willing to provide signed informed consent to clinical investigation participation.
•4. Patients who agree to discontinue all dermatological treatment and procedures during the study.
•5. Patients able to communicate adequately with the Investigator and to comply with the requirements for the study.

Exclusion Criteria

•1. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study.
•\*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
•2. Patients with history of allergy or hypersensitivity to Hyaluronic Acid or to any other ingredients of Ialuxid® Gel or hypersensitivity skin reaction to Ialuxid® Gel based on skin test results.
•3. History of anaphylaxis or severe complicated allergy symptoms.
•4. Patients with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma.
•5. Patients who have used oral drugs for acne vulgaris, and folliculitis in the previous month.
•6. Patients who have used topical therapies for acne vulgaris, and folliculitis in the previous month.
•7. Use of concomitant treatments or procedures aimed to improve skin condition over the last six months before the enrolment, such as chemical peeling, dermabrasion, laser resurfacing.
•8. Patients suffering from infectious diseases that would compromise participation, including herpes simplex virus infection, active hepatitis, or human immunodeficiency virus.
•9. Patients at risk in term of precautions, warnings and contra-indications referred in the package insert of Ialuxid® Gel.
+7 more criteria

Locations (1)

SC Salvosan Ciobanca SRL

Zalău, Sălaj County, Romania

Key Dates

Start Date

November 11, 2022

Primary Completion Date

September 22, 2023

Completion Date

September 22, 2023

Last Updated

May 21, 2024

Enrollment

ACTUAL participants

Conditions

Acne VulgarisFolliculitis

Interventions

Ialuxid gel

DEVICE

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne