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

Primary Purpose

Acne Vulgaris, Impetigo, Folliculitis

Status

Recruiting

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

Ialuxid gel

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women aged ≥ 18 and ≤ 45 years.
Patients diagnosed with acne vulgaris, impetigo, 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 Criteria:

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, impetigo and folliculitis in the previous month.
Patients who have used topical therapies for acne vulgaris, impetigo 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.

Sites / Locations

SC Salvosan Ciobanca SRLRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ialuxid Gel

Arm Description

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

Outcomes

Primary Outcome Measures

Change in total number of lesions

To evaluate the overall performance of the medical device Ialuxid Gel in the treatment of acne vulgaris, impetigo, 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).

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Change in total number of lesions

To evaluate the overall performance of the medical device Ialuxid® Gel in the treatment of acne vulgaris, impetigo, and folliculitis in terms of change in the total number of lesions, according to lesions count performed by Investigator

Global Acne Grading System (GAGS)

To assess acne vulgaris severity by means of the Global Acne Grading System (GAGS) score, assessed by Investigator. Only for patients affected by acne vulgaris. The grading system score evaluates the acne severity from a minimum score of 0 (no acne) to >39 (very severe acne).

Skin Infection Rating Scale (SIRS)

To assess impetigo severity by means of the Skin Infection Rating Scale (SIRS) score, assessed by Investigator. Only for patients affected by impetigo. The scale evaluates 5 categories of symptoms (Erythema, Pus, Crusting, Pain, Itching) from 0 (absent) to 3 (severe).

Total Severity Score (TSS)

To assess the total number of patients having a decrease in the global severity of the disease by means of the Total Severity Score (TSS), assessed by Investigator. The scale evaluates of symptoms of each diseases (for folliculitis-pustule and inflammatory nodules; for impetigo-vesicles, bullae, pustules, crust; for acne vulgaris- comedones, papules, pustules, nodules, cysts, abscesses) from 0 (absent) to 3 (severe).

Treatment satisfaction questionnaire

To assess the patient satisfaction by means of the treatment satisfaction questionnaire, assessed by patient, providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)

Investigator Global Assessment of Performance (IGAP)

To evaluate the global performance of Ialuxid® Gel by means of the Investigator Global Assessment of Performance (IGAP), assessed by Investigator, through photos taken at each visit. The scale evaluates the change on a 4 point scale from 1 meaning very good performance to 4 meaning poor performance)

Investigator Global Assessment of Performance (IGAS)

To evaluate the global safety of Ialuxid® Gel by means of the Investigator Assessment of Performance (IGAS) assessed by the Investigator, providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.

Patient Global Assessment of Performance (PGAS)

To evaluate the global safety of Ialuxid® Gel by means of the Patient Assessment of Performance (PGAS) assessed by the patient, providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.

Dermatology Life Quality Index (DLQI)

To assess the quality of life by means of the Dermatology Life Quality Index (DLQI) score, assessed by patients, providing the impact the disease had on the subjects life in various scenarios from not at all to very much

Full Information

NCT ID

NCT05345093

First Posted

April 19, 2022

Last Updated

May 3, 2023

Sponsor

BMG Pharma

Collaborators

Opera CRO, a TIGERMED Group Company

1. Study Identification

Unique Protocol Identification Number

NCT05345093

Brief Title

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

Official Title

Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid Gel in the Treatment of Acne Vulgaris, Impetigo and Folliculitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2022 (Actual)

Primary Completion Date

September 4, 2023 (Anticipated)

Study Completion Date

October 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BMG Pharma

Collaborators

Opera CRO, a TIGERMED Group Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, impetigo, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris, Impetigo, Folliculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ialuxid Gel

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Ialuxid gel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in total number of lesions

Description

Time Frame

8 weeks

Title

Adverse event incidence

Description

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

Time Frame

8 weeks

Title

Serious Adverse event incidence

Description

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.

Time Frame

8 weeks

Title

Adverse Device event incidence

Description

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.

Time Frame

8 weeks

Title

Serious Adverse Device event incidence

Description

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.

Time Frame

8 weeks

Title

Anticipated Serious Adverse Device event incidence

Description

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.

Time Frame

8 weeks

Title

Unexpected Serious Adverse Device event incidence

Description

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.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in total number of lesions

Description

Time Frame

4 weeks

Title

Global Acne Grading System (GAGS)

Description

Time Frame

8 weeks

Title

Skin Infection Rating Scale (SIRS)

Description

Time Frame

8 weeks

Title

Total Severity Score (TSS)

Description

Time Frame

8 weeks

Title

Treatment satisfaction questionnaire

Description

Time Frame

8 weeks

Title

Investigator Global Assessment of Performance (IGAP)

Description

Time Frame

8 weeks

Title

Investigator Global Assessment of Performance (IGAS)

Description

Time Frame

8 weeks

Title

Patient Global Assessment of Performance (PGAS)

Description

Time Frame

8 weeks

Title

Dermatology Life Quality Index (DLQI)

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women aged ≥ 18 and ≤ 45 years. Patients diagnosed with acne vulgaris, impetigo, 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 Criteria: 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, impetigo and folliculitis in the previous month. Patients who have used topical therapies for acne vulgaris, impetigo 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Petronela Mitrica

Phone

+40 755 660 015

vladgheorghiteanu@yahoo.co.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Vlad Gheorghiteanu

Phone

+40 755 660 015

vladgheorghiteanu@yahoo.co.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petronela Mitrica

Organizational Affiliation

Salvosan-Ciobanca

Official's Role

Principal Investigator

Facility Information:

Facility Name

SC Salvosan Ciobanca SRL

City

Zalău

State/Province

Salaj

ZIP/Postal Code

450117

Country

Romania

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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