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

A study testing Ialuxid gel in people with Acne Vulgaris and Folliculitis, run by BMG Pharma at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Acne Vulgaris, Folliculitis
What is being tested?: Ialuxid gel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteRomania
Study dates: 11 Nov 2022to 22 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Romania1 site

SC Salvosan Ciobanca SRL
Zalău, Sălaj County, 450117

Other trials in Romania

About this study

Official title: 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.

Read the 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.

Conditions: Acne Vulgaris, Folliculitis
Being tested: Ialuxid gel
Medical subject headings: Acne Vulgaris, Folliculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ialuxid gelDevice
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.

Study groups in NCT05345093
Study group	Role	What they receive
Ialuxid Gel	Experimental	twenty-two patients affected by acne vulgaris; twenty-two patients affected by folliculitis. Receives: Device: Ialuxid gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (8)

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
Measured: 4 weeks
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).
Measured: 8 weeks
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 acne vulgaris - comedones, papules, pustules, nodules, cysts, abscesses) from 0 (absent) to 3 (severe).
Measured: 8 weeks
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)
Measured: 8 weeks
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)
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202222 Sep 2023

First posted25 Apr 2022
Study start11 Nov 2022
Primary completion22 Sep 2023
Study completion22 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05345093
Sponsor's protocol ID: OPBMG/0122/MD
Status last verified: May 2024
First submitted: 19 Apr 2022
Last updated: 21 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Alsulaimani H, Kokandi A, Khawandanh S, Hamad R. Severity of Acne Vulgaris: Comparison of Two Assessment Methods. Clin Cosmet Investig Dermatol. 2020 Sep 28;13:711-716. doi: 10.2147/CCID.S266320. eCollection 2020.
PubMed 33061511
Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
PubMed 23125964
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
PubMed 18795920
Gravitz L. Skin. Nature. 2018 Nov;563(7732):S83. doi: 10.1038/d41586-018-07428-4. No abstract available.
PubMed 30464282
Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
PubMed 9248884
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378
Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817.
PubMed 27453830
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64. doi: 10.1111/j.0022-202X.2005.23621.x.
PubMed 16185263
Inoue K, Takei K, Denda M. Functional glycine receptor in cultured human keratinocytes. Exp Dermatol. 2015 Apr;24(4):307-9. doi: 10.1111/exd.12651.
PubMed 25644897
Jiang LI, Stephens TJ, Goodman R. SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment. Skin Res Technol. 2013 Nov;19(4):492-8. doi: 10.1111/srt.12073. Epub 2013 Jun 10.
PubMed 23750828
Kapoor P, Kumar S. Hydrogen peroxide in dermatology. Indian J Dermatol Venereol Leprol. 2023 Jan-Mar;89(2):310-312. doi: 10.25259/IJDVL_292_2021. No abstract available.
PubMed 34623047
Keen MA. Hyaluronic Acid in Dermatology. Skinmed. 2017 Dec 1;15(6):441-448. eCollection 2017.
PubMed 29282181
Khavkin J, Ellis DA. Aging skin: histology, physiology, and pathology. Facial Plast Surg Clin North Am. 2011 May;19(2):229-34. doi: 10.1016/j.fsc.2011.04.003.
PubMed 21763983
Kim J, Ko Y, Park YK, Kim NI, Ha WK, Cho Y. Dietary effect of lactoferrin-enriched fermented milk on skin surface lipid and clinical improvement of acne vulgaris. Nutrition. 2010 Sep;26(9):902-9. doi: 10.1016/j.nut.2010.05.011.
PubMed 20692602
Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
PubMed 11711957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT05345093
Acronym / sponsor ID: OPBMG/0122/MD
Conditions: Acne Vulgaris, Folliculitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: BMG PharmaIndustry (pharma, biotech, devices)
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: 11 Nov 2022 (actual)
Primary completion: 22 Sep 2023 (actual)
Study completion: 22 Sep 2023 (actual)
First posted: 25 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ialuxid Gel	Experimental	Device: Ialuxid geltwenty-two patients affected by acne vulgaris; twenty-two patients affected by folliculitis.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ialuxid gelIaluxid® 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.	Device	Ialuxid Gel

Primary outcome

Change in total number of lesions
Time frame: 8 weeks
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).
Adverse event incidence
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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 secondary outcomes

Change in total number of lesions
Time frame: 4 weeks
Global Acne Grading System (GAGS)
Time frame: 8 weeks
Total Severity Score (TSS)
Time frame: 8 weeks
Treatment satisfaction questionnaire
Time frame: 8 weeks
Investigator Global Assessment of Performance (IGAP)
Time frame: 8 weeks
Investigator Global Assessment of Performance (IGAS)
Time frame: 8 weeks
Patient Global Assessment of Performance (PGAS)
Time frame: 8 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Background: PubMed 33061511Alsulaimani H, Kokandi A, Khawandanh S, Hamad R. Severity of Acne Vulgaris: Comparison of Two Assessment Methods. Clin Cosmet Investig Dermatol. 2020 Sep 28;13:711-716. doi: 10.2147/CCID.S266320. eCollection 2020.
Background: PubMed 23125964Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
Background: PubMed 18795920Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
Background: PubMed 30464282Gravitz L. Skin. Nature. 2018 Nov;563(7732):S83. doi: 10.1038/d41586-018-07428-4. No abstract available.
Background: PubMed 9248884Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
Background: PubMed 27453830Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817.
Background: PubMed 16185263Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64. doi: 10.1111/j.0022-202X.2005.23621.x.
Background: PubMed 25644897Inoue K, Takei K, Denda M. Functional glycine receptor in cultured human keratinocytes. Exp Dermatol. 2015 Apr;24(4):307-9. doi: 10.1111/exd.12651.
Background: PubMed 23750828Jiang LI, Stephens TJ, Goodman R. SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment. Skin Res Technol. 2013 Nov;19(4):492-8. doi: 10.1111/srt.12073. Epub 2013 Jun 10.
Background: PubMed 34623047Kapoor P, Kumar S. Hydrogen peroxide in dermatology. Indian J Dermatol Venereol Leprol. 2023 Jan-Mar;89(2):310-312. doi: 10.25259/IJDVL_292_2021. No abstract available.
Background: PubMed 29282181Keen MA. Hyaluronic Acid in Dermatology. Skinmed. 2017 Dec 1;15(6):441-448. eCollection 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Petronela Mitrica principal investigator

Salvosan-Ciobanca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ialuxid gel in people with Acne Vulgaris and Folliculitis, run by BMG Pharma at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total number of lesions (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05345093, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.