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NCT07596927
Epidermolysis bullosa (EB) is a rare condition that causes extreme fragility of the skin and mucous membranes, leading to the formation of painful blisters. It can be hereditary (HEB) or autoimmune (AEB), and its diagnosis requires invasive procedures such as biopsies. Saliva emerges as a promising alternative for diagnosis and monitoring, as it is easy to collect and contains relevant biomarkers. The disease has no cure, and care focuses on improving the daily lives of those affected. Lesions in oral soft tissues are common and affect functions such as chewing and speech. Photodynamic therapy (PDT), especially with curcumin, has shown positive results in treating oral lesions in other conditions due to its antimicrobial and anti-inflammatory properties. However, it has not yet been specifically studied in people with EB. The primary objective of this study is to evaluate the efficacy of PDT with curcumin in repairing oral lesions in people with EB. Secondary objectives are to assess the impact of photodynamic therapy on the quality of life of people with EB and to identify potential salivary biomarkers and their correlation with the current gold-standard markers of EB. Participant selection and research will be carried out at the Reference Center for Neurodevelopment, Care and Rehabilitation of Children (NINAR), in São Luís, Maranhão, in July 2025. Children, adolescents and adults diagnosed with EB who feed orally, as well as people without EB, will be included in the study. A single calibrated evaluator will be responsible for administering the questionnaires, performing the clinical examination, collecting saliva, and carrying out PDT. Demographic and socioeconomic information will be collected from participants and guardians. Dietary intake will be assessed using a 77-item food frequency questionnaire (FFQ) validated by ELSA-BRASIL (Chor et al., 2013). The following clinical data will be collected: dental caries, using the ICDAS system \[scores 0 (healthy tooth), 5 (visible dentinal cavity) and 6 (extensive cavity)\] (Ismail et al., 2007); molar-incisor hypomineralization (MIH), using the SES-MIH index (Cabral et al., 2019); soft tissue lesions (ulcers, vesicles, bullae), coloration (whitish, yellowish, reddish, etc.) and location (lips, tongue, palate, buccal mucosa, gingiva, etc.). Unstimulated saliva will be collected from EB participants at the NINAR facility and from non-EB participants (control) at the Ana Lúcia Chaves Fecury Clinical School. Saliva samples will be obtained using a 1 mL syringe between 7:00 and 10:00 AM, stored in Eppendorf tubes under refrigeration and subsequently in an ultrafreeze unit (-80°C) at the University of Ceuma. PDT will be performed with 0.1% curcumin gel, applied to the oral mucosal lesions for 5 minutes, followed by irradiation with a blue LED (Radii-CAL CX, 440/480 nm) for one and a half minutes. The procedure will be repeated for three consecutive days. Pain intensity will be monitored before and for seven days after treatment using the Wong-Baker FACES Scale (0 to 5). To assess the impact of treatment on the quality of life of children, the short-form Parental-Caregiver Perceptions Questionnaire (P-CPQ) will be completed by their parents or guardians. For adolescents (aged 12 and above) and adults, the Oral Health Impact Profile-14 (OHIP-14) will be applied. Both questionnaires will be administered before the 1st, 2nd, and 3rd PDT sessions. The reparative efficacy of PDT on lesions will be measured through clinical evaluation. Biochemical analyses will be performed at the laboratories of the Federal University of Uberlândia (UFU), including: metabolite extraction, mass spectrometry (ESI-MS and HPLC-MS), spectroscopy (ATR-FTIR), chemometric analysis, and identification of salivary biomarkers with the aid of artificial intelligence algorithms. Data will be subjected to descriptive analysis of qualitative variables (absolute and relative frequency) and quantitative variables (mean, standard deviation, median, and interquartile range). Statistical tests will be applied for intragroup comparison regarding treatment reparative efficacy and quality of life impact (before and after treatment days) and between groups (with and without EB) regarding salivary biomarkers. Statistical analyses will be conducted at a 5% significance level. SPSS for Windows (Version 20.0; SPSS Inc., Chicago) will be used for data analysis.
NCT04171661
Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.
NCT06563414
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).
NCT04213703
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
NCT03269474
The study will compare gene expression differences between blistered and non-blistered skin from individuals with all subtypes of EB, as well as normal skin from non-EB subjects. State of the art computational analysis will be performed to help identify new drugs that might help all EB wound healing and reduce pain. Researchers will focus on drugs that have already been approved for treatment of other dermatologic or non-dermatologic diseases, and therefore be repurposed for treatment of EB. Drug development is a very expensive process taking decades for execution. Drug repurposing on the other hand, significantly reduces the cost and shortens the amount of time that is needed to bring effective treatments to clinical use. To date, there is no specific treatment targeting the physiology and immunologic response in EB patients during wound healing. Market availability of repurposed medications will provide all EB patients rapid access to treatments, thus improving their quality of life.
NCT04908215
The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).
NCT05033574
The aim of the study is to determine the state of sexual development in patients with inherited epidermolysis bullosa; the study is planned to include boys and girls aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, Kindler syndrome.
NCT03605069
A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis with one or more pathogenic mutations in exon 73 in the COL7A1 gene.