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

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345093
• Other study ID #: OPBMG/0122/MD
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: May 2024
• Source: BMG Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 4 and 8 weeks after the beginning of the treatment?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Men or women aged = 18 and = 45 years.

2. Patients diagnosed with acne vulgaris, 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, and folliculitis in the previous month.

6. Patients who have used topical therapies for acne vulgaris, 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.

Related Conditions & MeSH terms

• Acne Vulgaris
• Folliculitis

Intervention

Device:
• Ialuxid gel
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.

Locations

Country	Name	City	State
Romania	SC Salvosan Ciobanca SRL	Zalau	Salaj

Sponsors (2)

Lead Sponsor	Collaborator
BMG Pharma	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Romania, 

References & Publications (28)

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. — View Citation

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. — View Citation

Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gravitz L. Skin. Nature. 2018 Nov;563(7732):S83. doi: 10.1038/d41586-018-07428-4. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Keen MA. Hyaluronic Acid in Dermatology. Skinmed. 2017 Dec 1;15(6):441-448. eCollection 2017. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Majtan J, Bucekova M, Jesenak M. Natural Products and Skin Diseases. Molecules. 2021 Jul 25;26(15):4489. doi: 10.3390/molecules26154489. — View Citation

Nardi NM, Schaefer TJ Impetigo [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430974/

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. Clinical Review Report: Ozenoxacin 1% Cream (Ozanex): (Ferrer Internacional, S.A.): Indication: The topicaltreatment of impetigo in patients aged two months and older [Internet]. Ottawa (ON): Canadian Agency forDrugs and Technologies in Health; 2018 Oct

Pereira H, Sousa DA, Cunha A, Andrade R, Espregueira-Mendes J, Oliveira JM, Reis RL. Hyaluronic Acid. Adv Exp Med Biol. 2018;1059:137-153. doi: 10.1007/978-3-319-76735-2_6. — View Citation

Reddy J, Rao V, Madhavulu B et al A randomized open label parallel group study comparing the safety, effectiveness and adherence between 2% fusidic acid cream versus 1% retapamulin ointment in children with impetigo International Journal of Basic & Clinical Pharmacology February 2019

Salwowska NM, Bebenek KA, Zadlo DA, Wcislo-Dziadecka DL. Physiochemical properties and application of hyaluronic acid: a systematic review. J Cosmet Dermatol. 2016 Dec;15(4):520-526. doi: 10.1111/jocd.12237. Epub 2016 Jun 21. — View Citation

Stephens TJ, Sigler ML, Herndon JH Jr, Dispensa L, Le Moigne A. A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen((R)) Time Perfection((R)) for improving the appearance of photodamaged skin. Clin Cosmet Investig Dermatol. 2016 Mar 15;9:63-70. doi: 10.2147/CCID.S98787. eCollection 2016. — View Citation

Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444. Erratum In: Clin Infect Dis. 2015 May 1;60(9):1448. Dosage error in article text. — View Citation

Sudha PN, Rose MH. Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9. — View Citation

Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne Vulgaris. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459173/ — View Citation

Veraldi S, Micali G, Berardesca E, Dall'Oglio F, Sinagra JL, Guanziroli E. Results of a Multicenter, Randomized, Controlled Trial of a Hydrogen Peroxide-based Kit versus a Benzoyl Peroxide-based Kit in Mild-to-moderate Acne. J Clin Aesthet Dermatol. 2016 Oct;9(10):50-54. Epub 2016 Oct 1. — View Citation

Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29. Erratum In: Lancet. 2012 Jan 28;379(9813):314. — View Citation

Winters RD, Mitchell M Folliculitis [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547754/

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	4 weeks
Secondary	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).	8 weeks
Secondary	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).	8 weeks
Secondary	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)	8 weeks
Secondary	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)	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks