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A Randomized Parallel, Controlled, Evaluator-Blinded Clinical Study on the Treatment of Viral Warts with Warm Therapy Combined with Hydrogen Peroxide (H2O2) Microneedle Patches

A Randomized Parallel, Controlled, Evaluator-Blinded Clinical Study on the Treatment of Viral Warts with Warm Therapy Combined with Hydrogen Peroxide (H2O2) Microneedle Patches

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113262
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral Warts

Interventions

Control group 1:Single heat therapy
Control group 2:Heat therapy combined with microneedle patch group (containing 9% saline)
Experimental group:Heat therapy combined with hydrogen peroxide (H?O?) microneedle patch group

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 6-65 years, no gender restriction; 2. Clinically diagnosed with common warts or palmar/plantar (toe) warts (number of lesions >=1), Physician's Wart Assessment score >=2 (0 points: no visible warts, no further treatment required; 1 point: visible warts, diameter less than 3mm; 2 points: single wart with diameter >=3mm and =6mm); 3. Subjects or legal guardians able to understand and sign the informed consent form/agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Subjects with clinically atypical warts; 2. Subjects with immune dysfunction or autoimmune diseases; 3. Pregnant or breastfeeding women; 4. Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months; 5. Subjects who have undergone the following systemic treatments within a certain period: immunomodulators/immunosuppressants (such as etanercept) within 4 months; glucocorticoids (inhaled or intranasal use allowed) within 1 month; 6. Subjects who have received the following treatments on the warts or around the warts within a certain period: laser or other photochemical therapy (intense pulsed light, photodynamic therapy) within 3 months; immunotherapy (candida antigen) within 4 months; liquid nitrogen within 2 months; hydrogen peroxide within 3 months; antimetabolic drug treatment (5-fluorouracil) within 2 months; vitamin A derivatives within 3 months; 7. Subjects who have previously had the following conditions before visiting: malignant skin tumors, precancerous skin lesions (actinic keratosis) within the past 6 months, or currently have an acute progression of skin or systemic diseases (such as psoriasis, atopic dermatitis, eczema, sun damage, etc.) or symptoms (such as sunburn, open wounds) that may increase risks from participating in the study or assessments; 8. Subjects with diseases affecting skin healing, such as diabetes or vitamin A deficiency; 9. Subjects with coexisting conditions like cryoglobulinemia, cold urticaria, or other cold sensitivity that may cause abnormal observations; 10. Subjects with severe dysfunction of the heart, lungs, liver, kidneys, or hematopoietic system.

Design outcomes

Primary

MeasureTime frame
Clinical and dermoscopic cure rates of subjects in the three treatment groups;Rate of change in clinical scores and dermoscopy scores;

Secondary

MeasureTime frame
Time of first rash peeling;Rate of change in target lesion area;VAS score, NRS-11 score change rate;Virus clearance rate;The impact of different virus types and genetic backgrounds on treatment response;

Countries

China

Contacts

Public ContactHao Guo

The First Hospital of China Medical University

guohao27@126.com+86 138 4036 5892

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026