Efficacy of low-dose 5-FU delivered via dissolving microneedle treating keloids Keloids, 5-Fluorouracil, Dissolving Microneedle patch
Conditions
Interventions
Intralesional 5-Fluorouracil (5-FU) is commonly used drug for treating keloids. In vivo and in vitro studies have shown that low-dose 5-FU injections can inhibit fibroblast proliferation and endotheli
Experimental Drug,Active Comparator Drug
5-FU DMN ,5-FU Intralesional injection
Sponsors
Faculty of Medicine, Thammasat University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria : 1. Males and females aged 18 to 65 years. 2. Patients with keloid scars that have been present for more than 1 year. 3. Patients with keloid scars measuring greater than or equal to 3 centimeters but not exceeding 10 centimeters. 4. Women who are menstruating must be advised on contraceptive measures and use contraceptive methods such as condoms or intrauterine devices for at least 14 days prior to joining the study and throughout the duration of participation. If using hormonal contraceptives, they must have been used for at least 30 days before participating in the study and must continue using the same type of hormonal contraceptive throughout the study duration.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Individuals who are pregnant, planning to become pregnant, or are breastfeeding. 2. Individuals who have received treatment for keloid scars with intralesional corticosteroid injections, corticosteroid tape and plaster, corticosteroid ointments and creams, or intralesional 5-fluorouracil, or those who have undergone laser or light treatment within 6 months prior to the start of the study. 3. Individuals with pre-existing conditions affecting the skin, such as atopic dermatitis, psoriasis, vitiligo, or other conditions that could cause skin abnormalities, such as diabetes mellitus, chronic renal failure, cirrhosis, or porphyria. 4. Individuals with underlying conditions related to immune system disorders, such as primary immunodeficiencies, HIV, anaphylaxis, asthma, generalized drug reactions, lymphoma, leukemia, rheumatoid arthritis, or systemic lupus erythematosus. 5. Individuals with a history of skin cancer, such as melanoma or squamous cell carcinoma, except for superficial basal cell carcinoma located in areas not close to the testing site. 6. Individuals who have received immunosuppressive medications within 3 weeks before participation in the study, such as cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immunoglobulin, Bacillus Calmette-Guerin, monoclonal antibodies, or radiation therapy. 7. Individuals who refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 0,4,8,12,24 week POSAS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume 0,4,8,12,24 week Antera 3D,Pain 0,4,8,12,24 week Visual analogue scale (VAS),Side effects 0,4,8,12,24 week - | — |
Countries
Thailand
Contacts
Public ContactWareeporn Disphanurat
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Outcome results
None listed