Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607875594537 Date of Registration: 06/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Methylene blue photodynamic therapy for treatment of common warts
Official scientific title Photodynamic immune modulation in common warts: the impact of methylene blue therapy
Brief summary describing the background and objectives of the trial Common warts are a frequent cutaneous manifestation of human papillomavirus (HPV) infection and may persist or recur despite conventional therapies. Photodynamic therapy using methylene blue has shown promising therapeutic effects, but its immunomodulatory mechanisms remain insufficiently understood. The present study aimed to assess the clinical and immunological effects of methylene blue-mediated photodynamic therapy in adult patients with multiple common warts. Thirty patients received intralesional methylene blue injections and topical liposomal methylene blue gel, followed by irradiation with red light, for up to five weekly treatment sessions. Clinical improvement of treated and untreated warts was assessed at 1 and 6 months and serum IL-2 and TNF-α were measured to assess systemic immune modulation.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) MB-PDT-Warts
Disease(s) or condition(s) being studied Common warts caused by human papillomavirus infection,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Methylene Blue Photodynamic Therapy One treatment session weekly for up to 5 sessions. Intralesional methylene blue (0.5% solution diluted to 100 mL) followed by topical liposomal methylene blue gel (50 µg/mL) and red light irradiation (640 nm, 80 J/cm², 10 minutes). Up to 5 weeks of treatment with follow-up at 1 month and 6 months. Patients with multiple common warts received methylene blue-mediated photodynamic therapy. One or two target lesions were injected with methylene blue and covered with liposomal methylene blue gel. After 60 minutes of occlusion, lesions were irradiated with red light (640 nm, 80 J/cm²) for 10 minutes. Treatment was administered once weekly for a maximum of five sessions. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of both sexes aged 18 years or older Presence of multiple clinically diagnosed common warts No topical, systemic, or procedural wart treatment within the preceding month Ability and willingness to provide informed consent Known hypersensitivity to methylene blue History of photosensitivity or diagnosed photodermatoses Pregnancy or lactation Severe autoimmune disease Uncontrolled diabetes mellitus Current or recent use of systemic corticosteroids or immunosuppressive therapy within the previous month Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/06/2026 Research Ethics Committee Faculty of Medicine for Girls AlAzhar University Cairo
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine for Girls AlAzhar University Nasr City Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage reduction in the size of treated common warts after methylene blue photodynamic therapy 1 month and 6 months after treatment
Secondary Outcome Change in serum IL-2 and TNF-alpha levels following methylene blue photodynamic therapy Baseline, 1 month and 6 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine for Girls AlAzhar University AlAzhar University Faculty of Medicine for Girls Nasr City Cairo 11765 Egypt
National Institute of Laser Enhanced Sciences Cairo University Cairo University Campus Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Fatma Badr Elkoumy Not Applicable Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine for Girls AlAzhar University Al Azhar University Faculty of Medicine for Girls Nasr City Cairo 11765 Egypt University
COLLABORATORS
Name Street address City Postal code Country
National Institute of Laser Enhanced Sciences Cairo University Cairo University Campus Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Elkoumy Fatmaelkomy@azhar.edu.eg +201157518751 Department of Dermatology and Venereology Faculty of Medicine for Girls AlAzhar University Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Department of Dermatology and Venereology Faculty of Medicine for Girls AlAzhar University
Role Name Email Phone Street address
Public Enquiries Fatma Elkoumy Fatmaelkomy@azhar.edu.eg +201157518751 Department of Dermatology and Venereology Faculty of Medicine for Girls AlAzhar University Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Department of Dermatology and Venereology Faculty of Medicine for Girls AlAzhar University
Role Name Email Phone Street address
Scientific Enquiries Fatma Elkoumy Fatmaelkomy@azhar.edu.eg +201157518751 Department of Dermatology and Venereology Faculty of Medicine for Girls AlAzhar University Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Department of Dermatology and Venereology Faculty of Medicine for Girls Al Azhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data underlying the results reported in this study will be available from the corresponding author upon reasonable request. De-identified participant data may be shared for scientific research purposes following review and approval of a research proposal. Informed Consent Form,Study Protocol Data will be available beginning 12 months after publication and will remain available for 5 years. Access will be granted to qualified researchers upon reasonable request, subject to approval by the principal investigator and institutional requirements.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/06/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/06/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 27/06/2026 the editor required that the brief should contain background This study evaluated the clinical and immunological effects of methylene blue-mediated photodynamic therapy in adult patients with multiple common warts. Thirty patients received up to five weekly treatment sessions using intralesional methylene blue, topical liposomal methylene blue gel, and red-light irradiation. Clinical improvement of treated and untreated warts was assessed at 1 and 6 months, and serum IL-2 and TNF-alpha levels were measured to evaluate systemic immune modulation. The study aimed to determine whether methylene blue photodynamic therapy improves wart lesions and affects cytokine dynamics related to immune response. Common warts are a frequent cutaneous manifestation of human papillomavirus (HPV) infection and may persist or recur despite conventional therapies. Photodynamic therapy using methylene blue has shown promising therapeutic effects, but its immunomodulatory mechanisms remain insufficiently understood. The present study aimed to assess the clinical and immunological effects of methylene blue-mediated photodynamic therapy in adult patients with multiple common warts. Thirty patients received intralesional methylene blue injections and topical liposomal methylene blue gel, followed by irradiation with red light, for up to five weekly treatment sessions. Clinical improvement of treated and untreated warts was assessed at 1 and 6 months and serum IL-2 and TNF-α were measured to assess systemic immune modulation.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/07/2026 PACTR Admin 01 Mar 2017
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/06/2026 The editor required that the Source Name should be the ACTUAL name of the Principal Self funded, Not Applicable, Cairo, , Egypt, Self Funded, Dr. Fatma Badr Elkoumy, Not Applicable, Cairo, , Egypt, Self Funded,