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

NCT05345093 | Completed

• 1 other identifier: OPBMG/0122/MD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Acne Vulgaris; Folliculitis

Outcome Measures

Primary Outcomes (7)

• Change in total number of lesions

  To evaluate the overall performance of the medical device Ialuxid Gel in the treatment of acne vulgaris, and folliculitis in terms of change in the total number of lesions, according to lesions count performed by Investigator (sum of lesions present on the body area mainly interested by each disease, to be specified in CRF).

  8 weeks

• Adverse event incidence

  To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

• Serious Adverse event incidence

  To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

• Adverse Device event incidence

  To evaluate the safety of the device trough Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

• Serious Adverse Device event incidence

  To evaluate the safety of the device trough Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

• Anticipated Serious Adverse Device event incidence

  To evaluate the safety of the device trough Anticipated Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

• Unexpected Serious Adverse Device event incidence

  To evaluate the safety of the device trough Unexpected Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.

  8 weeks

Secondary Outcomes (8)

• Change in total number of lesions

  4 weeks

• Global Acne Grading System (GAGS)

  8 weeks

• Total Severity Score (TSS)

  8 weeks

• Treatment satisfaction questionnaire

  8 weeks

• Investigator Global Assessment of Performance (IGAP)

  8 weeks

Study Arms (1)

Ialuxid Gel

EXPERIMENTAL

twenty-two patients affected by acne vulgaris; twenty-two patients affected by folliculitis.

Device: Ialuxid gel

Interventions

Ialuxid gel DEVICE

Ialuxid® Gel is intended for topical external use. It is formulated with the appearance of white to pale yellow coloured consistent gel. Ialuxid® Gel will be used for 8 weeks, 2-3 times a day.

Ialuxid Gel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BMG Pharma: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SC Salvosan Ciobanca SRL

Zalău, Sălaj County, 450117, Romania

Location

Related Publications (29)

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  BACKGROUND

• Stefancu ME, Barattini DF, Botnaru I, Vizman C, Stucchi L, Barattini L. Performance and Safety of the Medical Device Ialuxid Gel in the Treatment of Mild-Moderate Acne Vulgaris: An Open-Label, Noncomparative Multicentre Interventional Clinical Trial. J Cosmet Dermatol. 2025 Mar;24(3):e70084. doi: 10.1111/jocd.70084.

  PMID: 40029154 DERIVED

MeSH Terms

Conditions

Acne Vulgaris; Folliculitis

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Hair Diseases

Study Officials

• Petronela Mitrica

  Salvosan-Ciobanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: November 11, 2022
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

RO (1)