Efficacy and Safety of Platelet-rich Plasma, Metformin and Cryotherapy in Treatment of Non-genital Warts

NCT06691542 | Not Yet Recruiting Phase 2

• 1 other identifier: PRP, Metformin in warts
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Evaluation of the efficacy and safety of intralesional injection of autologous platelet-rich plasma in treatment of various types of cutaneous non genital warts
2. 2.Evaluation of the efficacy and safety of intralesional injection of metformin in treatment of various types of cutaneous non genital warts
3. 3.Comparing the efficacy and safety of intralesional injection of autologous platelet-rich plasma and intralesional injection of metformin with that of cryocautery in treatment of various types of cutaneous non genital warts.

Conditions

Non-Genital Warts

Outcome Measures

Primary Outcomes (1)

• Complete resolution of the wart(s) by disappearance of the wart and return of the normal skin markings

  Complete resolution of the wart(s) by disappearance of the wart and return of the normal skin markings

  3 months

Secondary Outcomes (3)

• •Change in size in millemeter

  3 months

• •Decrease in numbers of the warts

  3 months

• •Recurrence rates at 3 months for wart(s) with complete resolution.

  3 months

Study Arms (3)

Intralesional injection of Metformin

EXPERIMENTAL

Group 1: will include 36 patients with multiple common, plantar and/or plane warts. They will be treated by intralesional injection of metformin using insulin syringe every 2-weeks until complete clearance or for a maximum of 6 sessions.

Drug: Metformin

Intralesional injection of platelet- rich plasma

EXPERIMENTAL

Group 2: will include 36 patients with multiple common, plantar and/or plane warts. They will be treated by intralesional injection of platelet- rich plasma into the warts by an insulin syringe every 2 weeks until complete clearance or for a maximum of 6 sessions

Drug: platelet-rich plasma

Cryotherapy

EXPERIMENTAL

Group 3: will include 36 patients with multiple common, plantar and/or plane warts. They will receive cryotherapy sessions every two weeks until complete clearance or for a maximum of 6 sessions.

Other: cryotherapy

Interventions

platelet-rich plasma DRUG

platelet-rich plasma, metformin and cryotherapy in treatment of non-genital warts

Intralesional injection of platelet- rich plasma

Metformin DRUG

platelet-rich plasma, metformin and cryotherapy in treatment of non-genital warts

Intralesional injection of Metformin

cryotherapy OTHER

platelet-rich plasma, metformin and cryotherapy in treatment of non-genital warts

Cryotherapy

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with cutaneous (extragenital) viral warts (single , new or recurrent, common, plane and/or planter warts.
• Age ranged from 8 to 60 years old.
• No concurrent systemic or topical treatment of warts.

You may not qualify if:

• Patients with fever or signs of any inflammation or infection
• Pregnancy and lactation.
• Immunosuppression or being under any kind of treatment causing absolute or relative immunosuppression.
• History of any bleeding, clotting disorder or using anticoagulants
• Chronic systemic diseases such as diabetes, chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
• atients using concurrent treatments for warts or one month before .
• Any generalized dermatitis, allergic skin disorders

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• Zhu P, Qi RQ, Yang Y, Huo W, Zhang Y, He L, Wang G, Xu J, Zhang F, Yang R, Tu P, Ma L, Liu Q, Li Y, Gu H, Cheng B, Chen X, Chen A, Xiao S, Jin H, Zhang J, Li S, Yao Z, Pan W, Yang H, Shen Z, Cheng H, Song P, Fu L, Chen H, Geng S, Zeng K, Wang J, Tao J, Chen Y, Wang X, Gao XH. Clinical guideline for the diagnosis and treatment of cutaneous warts (2022). J Evid Based Med. 2022 Sep;15(3):284-301. doi: 10.1111/jebm.12494. Epub 2022 Sep 18.

  PMID: 36117295 BACKGROUND

• Araujo MG, Magalhaes GM, Garcia LC, Vieira EC, Carvalho-Leite MLR, Guedes ACM. Update on human papillomavirus - Part II: complementary diagnosis, treatment and prophylaxis. An Bras Dermatol. 2021 Mar-Apr;96(2):125-138. doi: 10.1016/j.abd.2020.11.005. Epub 2021 Feb 16.

  PMID: 33637397 BACKGROUND

• Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.

  PMID: 25273231 BACKGROUND

• Bacelieri R, Johnson SM. Cutaneous warts: an evidence-based approach to therapy. Am Fam Physician. 2005 Aug 15;72(4):647-52.

  PMID: 16127954 BACKGROUND

• Focht DR 3rd, Spicer C, Fairchok MP. The efficacy of duct tape vs cryotherapy in the treatment of verruca vulgaris (the common wart). Arch Pediatr Adolesc Med. 2002 Oct;156(10):971-4. doi: 10.1001/archpedi.156.10.971.

  PMID: 12361440 BACKGROUND

• Abu El-Hamd M, Aboeldahab S. Possible clinical efficacy and tolerability of platelet-rich plasma in the treatment of patients with recalcitrant plane warts: The first clinical study. J Cosmet Dermatol. 2021 Nov;20(11):3623-3629. doi: 10.1111/jocd.14008. Epub 2021 Mar 1.

  PMID: 33599062 BACKGROUND

• Abu El-Hamd M, Aboeldahab S. A case of resistant multiple plantar warts cured with combined autologous platelet-rich plasma injection and topical salicylic acid 30. J Cosmet Dermatol. 2022 Jun;21(6):2417-2419. doi: 10.1111/jocd.14468. Epub 2021 Sep 24.

  PMID: 34559938 BACKGROUND

• McDonald B, Dunbar M. Platelets and Intravascular Immunity: Guardians of the Vascular Space During Bloodstream Infections and Sepsis. Front Immunol. 2019 Oct 11;10:2400. doi: 10.3389/fimmu.2019.02400. eCollection 2019.

  PMID: 31681291 BACKGROUND

• Henn V, Slupsky JR, Grafe M, Anagnostopoulos I, Forster R, Muller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. doi: 10.1038/35393.

  PMID: 9468137 BACKGROUND

• Flad HD, Brandt E. Platelet-derived chemokines: pathophysiology and therapeutic aspects. Cell Mol Life Sci. 2010 Jul;67(14):2363-86. doi: 10.1007/s00018-010-0306-x. Epub 2010 Mar 7.

  PMID: 20213276 BACKGROUND

• Chen X, Guo H, Qiu L, Zhang C, Deng Q, Leng Q. Immunomodulatory and Antiviral Activity of Metformin and Its Potential Implications in Treating Coronavirus Disease 2019 and Lung Injury. Front Immunol. 2020 Aug 18;11:2056. doi: 10.3389/fimmu.2020.02056. eCollection 2020.

  PMID: 32973814 BACKGROUND

• Benedetti F, Sorrenti V, Buriani A, Fortinguerra S, Scapagnini G, Zella D. Resveratrol, Rapamycin and Metformin as Modulators of Antiviral Pathways. Viruses. 2020 Dec 17;12(12):1458. doi: 10.3390/v12121458.

  PMID: 33348714 BACKGROUND

• Hoppe-Seyler K, Herrmann AL, Daschle A, Kuhn BJ, Strobel TD, Lohrey C, Bulkescher J, Krijgsveld J, Hoppe-Seyler F. Effects of Metformin on the virus/host cell crosstalk in human papillomavirus-positive cancer cells. Int J Cancer. 2021 Sep 1;149(5):1137-1149. doi: 10.1002/ijc.33594. Epub 2021 May 6.

  PMID: 33844847 BACKGROUND

• Abou-Taleb DAE, Abou-Taleb HA, El-Badawy O, Ahmed AO, Thabiet Hassan AE, Awad SM. Intralesional vitamin D3 versus intralesional purified protein derivative in treatment of multiple warts: A comparative clinical and immunological study. Dermatol Ther. 2019 Sep;32(5):e13034. doi: 10.1111/dth.13034. Epub 2019 Aug 7.

  PMID: 31355514 BACKGROUND

• Abd El-Magiud EM, Abd El-Samea GM, Gaber HD. Intralesional injection of measles, mumps, and rubella vaccine versus cryotherapy in treatment of warts: A randomized controlled trial. Dermatol Ther. 2020 Mar;33(2):e13257. doi: 10.1111/dth.13257. Epub 2020 Feb 16.

  PMID: 32031726 BACKGROUND

MeSH Terms

Interventions

Metformin; Cryotherapy

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Therapeutics

Study Officials

• Eman Mohamed Kamal Elsayed Youssef, prof

  Professor of Dermatology and Venereology Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

• Alaa Mohamed Mahmoud Hamdy Ghazally, Lecturer

  Lecturer of Dermatology and Venereology Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Gamal Abd El-Wahab Mahmoud

CONTACT

01151448835; geemy2011@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: November 15, 2024
• Study Start: November 14, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11