Clinical trial NCT05345093: Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Folliculitis
Lead sponsor: BMG Pharma
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2022-04-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total number of lesions
timeFrame: 8 weeks
measure: Adverse event incidence
timeFrame: 8 weeks
measure: Serious Adverse event incidence
timeFrame: 8 weeks
measure: Adverse Device event incidence
timeFrame: 8 weeks
measure: Serious Adverse Device event incidence
timeFrame: 8 weeks
measure: Anticipated Serious Adverse Device event incidence
timeFrame: 8 weeks
measure: Unexpected Serious Adverse Device event incidence
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in total number of lesions
timeFrame: 4 weeks
measure: Global Acne Grading System (GAGS)
timeFrame: 8 weeks
measure: Total Severity Score (TSS)
timeFrame: 8 weeks
measure: Treatment satisfaction questionnaire
timeFrame: 8 weeks
measure: Investigator Global Assessment of Performance (IGAP)
timeFrame: 8 weeks
measure: Investigator Global Assessment of Performance (IGAS)
timeFrame: 8 weeks
measure: Patient Global Assessment of Performance (PGAS)
timeFrame: 8 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zalău
country: Romania
facility: SC Salvosan Ciobanca SRL
state: Salaj
Study officials:
affiliation: Salvosan-Ciobanca
name: Petronela Mitrica
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
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.
citation: Gravitz L. Skin. Nature. 2018 Nov;563(7732):S83. doi: 10.1038/d41586-018-07428-4. No abstract available.
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.
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.
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.
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.
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.
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.
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.
citation: Keen MA. Hyaluronic Acid in Dermatology. Skinmed. 2017 Dec 1;15(6):441-448. eCollection 2017.
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.
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.
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.
citation: Majtan J, Bucekova M, Jesenak M. Natural Products and Skin Diseases. Molecules. 2021 Jul 25;26(15):4489. doi: 10.3390/molecules26154489.
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/
citation: 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
citation: 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.
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
citation: 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.
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.
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.
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.
citation: Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne Vulgaris. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459173/
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.
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.
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/