Photodynamic Therapy in Treatment of Verrucae

NCT04620785 — Not applicable, Unknown, 80 participants, Alexandria University

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PHOTODYNAMIC THERAPY USING METHYLENE BLUE AND INTENSE PULSED LIGHT VERSUS INTENSE PULSED LIGHT ALONE IN TREATMENT OF VERRUCA :A RANDOMIZED CONTROLLED STUDY

Registry	NCT04620785
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Verruca Vulgaris
Interventions	methylene blue / IPL, IPL, saline (Other)
Dates	start 2020-01-01, primary completion 2022-05-01 (estimated), completion 2022-05-01 (estimated), first posted 2020-11-09, last updated 2021-07-26
Locations	1 site in Egypt

-Summary

To assess the efficacy (clinically and dermoscopically) and safety of photodynamic therapy using intralesional injection of 4% methylene blue solution as a photosensitizer with IPL versus IPL only in treatment of warts.

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+Detailed description

This study will be conducted on:

Eighty patients suffering of verruca (male and female) divided randomly into three groups: group A, B\&C :

Group A: 30 patients will undergo photodynamic therapy using intralesional 4%methylene blue solution and IPL.

Group B: 30 patients will undergo IPL only. Group C (control group):20 patients will undergo intralesional saline.

+Arms and interventions

Arm	Type	Interventions	Description
methylene blue/IPL	Experimental	Other: methylene blue / IPL	will undergo photodynamic therapy using intralesional 4%methylene blue solution ,after a period of 15 minutes the patient will be subjected to IPL session. This will be repeated biweekly until complete clearance of the lesion or a maximum four sessions.
IPL	Experimental	Other: IPL	will undergo biweekly IPL sessions only until complete clearance of the lesion or a maximum four sessions.
saline	Placebo comparator	Other: saline	will undergo intralesional saline.

methylene blue / IPL (Other): therapeutic
IPL (Other): therapeutic
saline (Other): placebo

+Outcome measures

Primary outcomes

disappearance of verruca [10 weeks]: clinical and dermoscopic cure

+Eligibility

Sex: All, ages: 16 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Age:Above 16 years old.
2. Sex:Both males and female patients.
3. Clinically and dermoscopically documented verruca.
4. No verruca treatment in the last 2 weeks.

Exclusion Criteria:

1. History of photosensitivity disorder.
2. Pregnant and lactating females.
3. Diseases with risk of koebnerization e.g. Psoriasis and Lichen planus.
4. Anogenital warts.
5. Warts on head and neck.

+Locations (1)

Facility	City	Country	Status
Alexandria University Faculty of Medicine	Alexandria	Egypt	Recruiting