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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
Sponsored by
BMG Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. Men or women aged ≥ 18 and ≤ 45 years.
  2. Patients diagnosed with acne vulgaris, impetigo, 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, impetigo and folliculitis in the previous month.
  6. Patients who have used topical therapies for acne vulgaris, impetigo 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.
  10. 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.
  11. Patients who received filler injections of any typology in the face in the preceding 3 months.
  12. Patients who received botulinum toxin A injections in the face in the preceding 6 months.
  13. Need to have direct or indirect contact with quaternary ammonium salts during the study.
  14. Patients unlikely to cooperate.
  15. 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.
  16. 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

First Posted
April 19, 2022
Last Updated
May 3, 2023
Sponsor
BMG Pharma
Collaborators
Opera CRO, a TIGERMED Group Company
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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).
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
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
Time Frame
4 weeks
Title
Global Acne Grading System (GAGS)
Description
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).
Time Frame
8 weeks
Title
Skin Infection Rating Scale (SIRS)
Description
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).
Time Frame
8 weeks
Title
Total Severity Score (TSS)
Description
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).
Time Frame
8 weeks
Title
Treatment satisfaction questionnaire
Description
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)
Time Frame
8 weeks
Title
Investigator Global Assessment of Performance (IGAP)
Description
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)
Time Frame
8 weeks
Title
Investigator Global Assessment of Performance (IGAS)
Description
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.
Time Frame
8 weeks
Title
Patient Global Assessment of Performance (PGAS)
Description
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.
Time Frame
8 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
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
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
No
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
Email
vladgheorghiteanu@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Vlad Gheorghiteanu
Phone
+40 755 660 015
Email
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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