Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts

NCT05300009 | Unknown

• 1 other identifier: MGMW
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the clinical efficacy of the topically applied MTX hydrogel preparation combined with microneedling to increase drug delivery and efficacy in comparison with cryotherapy in treatment of warts.

Conditions

Warts

Outcome Measures

Primary Outcomes (3)

• Complete resolution of all treated wart(s).

  Proportion of participants with total remission of wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator and photographic evaluation . Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings).

  8 weeks

• Partial resolution

  Number of subjects achieving partial resolution of treated wart(s) at the end of the intervention in the two arms of the clinical trial assessed by the investigator, photographic evaluation and The following grading system : Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response. Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the stud

  8 weeks

• Incidence of adverse events

  Proportion of participants that developed a serious side effect in the two arms during the clinical trial.

  8 weeks

Study Arms (2)

topical methotrexate hydrogel 1% coupled with microneedling

EXPERIMENTAL

patients who will receive topical methotrexate hydrogel 1% coupled with microneedling

Combination Product: topical methotrexate hydrogel 1% coupled with microneedling.

cryotherapy

ACTIVE COMPARATOR

patients who will receive cryotherapy

Other: Liquid nitrogen

Interventions

topical methotrexate hydrogel 1% coupled with microneedling. COMBINATION_PRODUCT

Microneedling will be performed on each wart for a maximum 5 lesions per patient using dermapen (Ostar rechargeable dermapen, OB-DG 03N, Ostar Beauty Sci-Tech Co, Beijing, China) supplied with 12 needles arranged in rows. The penetration depth was adjusted at 2-mm, endpoint was pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the wart. Then topical methotrexate 1% gel will be applied on the lesions every session.

topical methotrexate hydrogel 1% coupled with microneedling

Liquid nitrogen OTHER

The wart is frozen for 10 to 30 seconds until a 1- to 2-mm ice ball halo surrounds the targeted area. The sessions were performed every 2 week until complete clearance for a maximum of six sessions.

cryotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients older than 18 years up to 60 years old.
• Patients with plantar or common warts.

You may not qualify if:

• 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 chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
• concurrent use of systemic or topical treatments of warts .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Ghittoni R, Accardi R, Chiocca S, Tommasino M. Role of human papillomaviruses in carcinogenesis. Ecancermedicalscience. 2015 Apr 29;9:526. doi: 10.3332/ecancer.2015.526. eCollection 2015.

  PMID: 25987895 BACKGROUND

• Kimura U, Takeuchi K, Kinoshita A, Takamori K, Suga Y. Long-pulsed 1064-nm neodymium:yttrium-aluminum-garnet laser treatment for refractory warts on hands and feet. J Dermatol. 2014 Mar;41(3):252-7. doi: 10.1111/1346-8138.12411. Epub 2014 Feb 10.

  PMID: 24506821 BACKGROUND

• Shaheen MA, Salem SA, Fouad DA, El-Fatah AA. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study. Dermatol Ther. 2015 Jul-Aug;28(4):194-200. doi: 10.1111/dth.12230. Epub 2015 Apr 6.

  PMID: 25847793 BACKGROUND

• Sung JY, Hong JH, Kang HS, Choi I, Lim SD, Lee JK, Seok JH, Lee JH, Hur GM. Methotrexate suppresses the interleukin-6 induced generation of reactive oxygen species in the synoviocytes of rheumatoid arthritis. Immunopharmacology. 2000 Apr;47(1):35-44. doi: 10.1016/s0162-3109(99)00185-x.

  PMID: 10708808 BACKGROUND

• Cipriani P, Ruscitti P, Carubbi F, Liakouli V, Giacomelli R. Methotrexate: an old new drug in autoimmune disease. Expert Rev Clin Immunol. 2014 Nov;10(11):1519-30. doi: 10.1586/1744666X.2014.962996. Epub 2014 Sep 22.

  PMID: 25245537 BACKGROUND

• Beck S, Zhu Z, Oliveira MF, Smith DM, Rich JN, Bernatchez JA, Siqueira-Neto JL. Mechanism of Action of Methotrexate Against Zika Virus. Viruses. 2019 Apr 10;11(4):338. doi: 10.3390/v11040338.

  PMID: 30974762 BACKGROUND

• Duarte AA, Carneiro GP, Murari CM, Jesus LCB. Nail psoriasis treated with intralesional methotrexate infiltration. An Bras Dermatol. 2019 Oct 17;94(4):491-492. doi: 10.1590/abd1806-4841.20198170. eCollection 2019. No abstract available.

  PMID: 31644634 BACKGROUND

• Sutton L, Swinehart JM, Cato A, Kaplan AS. A clinical study to determine the efficacy and safety of 1% methotrexate/Azone (MAZ) gel applied topically once daily in patients with psoriasis vulgaris. Int J Dermatol. 2001 Jul;40(7):464-7. doi: 10.1046/j.1365-4362.2001.01244.x. No abstract available.

  PMID: 11679005 BACKGROUND

• Abdo HM, Elrewiny EM, Elkholy MS, Ibrahim SM. Efficacy of intralesional methotrexate in the treatment of plantar warts. Dermatol Ther. 2020 Mar;33(2):e13228. doi: 10.1111/dth.13228. Epub 2020 Jan 29.

  PMID: 31965678 BACKGROUND

• Dehshahri A, Kumar A, Madamsetty VS, Uzieliene I, Tavakol S, Azedi F, Fekri HS, Zarrabi A, Mohammadinejad R, Thakur VK. New Horizons in Hydrogels for Methotrexate Delivery. Gels. 2020 Dec 30;7(1):2. doi: 10.3390/gels7010002.

  PMID: 33396629 BACKGROUND

• Badran MM, Kuntsche J, Fahr A. Skin penetration enhancement by a microneedle device (Dermaroller) in vitro: dependency on needle size and applied formulation. Eur J Pharm Sci. 2009 Mar 2;36(4-5):511-23. doi: 10.1016/j.ejps.2008.12.008. Epub 2008 Dec 25.

  PMID: 19146954 BACKGROUND

• Ita K. Dissolving microneedles for transdermal drug delivery: Advances and challenges. Biomed Pharmacother. 2017 Sep;93:1116-1127. doi: 10.1016/j.biopha.2017.07.019. Epub 2017 Jul 19.

  PMID: 28738520 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Family Characteristics; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Khulood F Alhakami, M.B.B.CH

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman R Mohamed, Professor

CONTACT

+201005298992; e_riad@yahoo.com

Heba H Sayed, Lecturer

CONTACT

+201002866919; hebahasan16888@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 29, 2022
• Study Start: June 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: August 15, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share