Status:
COMPLETED
Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis
Lead Sponsor:
BMG Pharma
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Acne Vulgaris
Folliculitis
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 gly...
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 associ...
Eligibility Criteria
Inclusion
- Men or women aged ≥ 18 and ≤ 45 years.
- Patients diagnosed with acne vulgaris, and folliculitis.
- a. Only for patients with acne vulgaris: mild to moderate Global Acne Grading Scale score (≤ 30).
- Patients willing to provide signed informed consent to clinical investigation participation.
- Patients who agree to discontinue all dermatological treatment and procedures during the study.
- Patients able to communicate adequately with the Investigator and to comply with the requirements for the study.
Exclusion
- 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.).
- 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.
- History of anaphylaxis or severe complicated allergy symptoms.
- Patients with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma.
- Patients who have used oral drugs for acne vulgaris, and folliculitis in the previous month.
- Patients who have used topical therapies for acne vulgaris, and folliculitis in the previous month.
- 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.
- Patients suffering from infectious diseases that would compromise participation, including herpes simplex virus infection, active hepatitis, or human immunodeficiency virus.
- Patients at risk in term of precautions, warnings and contra-indications referred in the package insert of Ialuxid® Gel.
- Patients with any facial aesthetic surgery (such as facial contouring surgery: rhinoplasty, chin, or cheek enhancement (through facial implant) or facial rejuvenation surgery: facelift, eyelid lift, neck lift or facial implants etc.) in the preceding 3 months before the enrolment.
- Patients who received filler injections of any typology in the face in the preceding 3 months.
- Patients who received botulinum toxin A injections in the face in the preceding 6 months.
- Need to have direct or indirect contact with quaternary ammonium salts during the study.
- Patients unlikely to cooperate.
- Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05345093
Start Date
November 11 2022
End Date
September 22 2023
Last Update
May 21 2024
Active Locations (1)
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1
SC Salvosan Ciobanca SRL
Zalău, Sălaj County, Romania, 450117