Curcumin-Based Photodynamic Therapy in Epidermolysis Bullosa: Wound Healing, Quality of Life, and Salivary Biomarkers

NCT07596927 | Active Not Recruiting Phase 4

• 1 other identifier: CURE-EB-PTD-2026-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidermolysis Bullosa Acquisita; Epidermolysis Bullosa (EB); Epidermolysis Bullosa Dystrophica

Keywords

Photodynamic Therapy; Epidermolysis Bullosa; Salivary Biomarkers

Outcome Measures

Primary Outcomes (1)

• Tissue Repair of Oral Vesiculobullous Lesions

  The primary outcome is the clinical evaluation of tissue repair in oral vesiculobullous lesions following curcumin-mediated photodynamic therapy. Lesions will be assessed through standardized oral examination considering presence, type (ulcer, vesicle, or blister), color, and anatomical location. Changes in lesion characteristics and healing progression will be evaluated by a single calibrated examiner. Improvement will be defined by reduction or resolution of lesions and overall clinical appearance of mucosal healing after treatment.

  Baseline (pre-treatment) and daily assessment for 7 days after completion of the 3-day treatment protocol.

Study Arms (1)

Curcumin Photodynamic Therapy in EB Patients

EXPERIMENTAL

Participants diagnosed with epidermolysis bullosa (EB) will receive curcumin-mediated photodynamic therapy (PDT) for the treatment of oral vesiculobullous lesions. The intervention consists of topical application of 0.1% curcumin gel directly onto oral lesions, maintained for 5 minutes, followed by irradiation with a blue LED light source (wavelength 440-480 nm) for approximately 90 seconds (≈9 J). The procedure will be performed once daily for three consecutive days. Clinical evaluation of lesions, pain assessment using the Wong-Baker Faces Pain Scale, and quality of life questionnaires (P-CPQ or OHIP-14) will be conducted before and after treatment. Saliva samples will also be collected for biomarker analysis.

Drug: Curcumin-based photodynamic therapy

Interventions

Curcumin-based photodynamic therapy DRUG

Curcumin-mediated photodynamic therapy (PDT) will be applied to oral vesiculobullous lesions in patients with epidermolysis bullosa. A 0.1% curcumin gel will be topically administered directly onto the lesion and maintained for 5 minutes to allow adequate tissue absorption. Following this, the area will be irradiated using a blue LED light source with a wavelength of 440-480 nm for approximately 90 seconds, delivering an estimated energy dose of 9 J using a scanning technique. The procedure will be performed once daily for three consecutive days. This protocol is standardized and performed by a single calibrated examiner to ensure consistency. The intervention is non-invasive and aims to promote tissue repair, reduce microbial load, and alleviate pain associated with oral lesions.

Curcumin Photodynamic Therapy in EB Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children, adolescents, and adults diagnosed with epidermolysis bullosa (EB), regardless of subtype
• Participants who are able to receive oral feeding Individuals receiving care at the NINAR Reference Center or residing in São Luís or the state of Maranhão
• Participants (or legal guardians) who provide written informed consent; assent obtained from minors when applicable
• Ability to undergo oral clinical examination and photodynamic therapy procedures

You may not qualify if:

• Individuals with epidermolysis bullosa who present physical and/or mental conditions that prevent cooperation with oral examination or treatment procedures
• Participants unable to comply with study procedures, including clinical evaluation, saliva collection, or photodynamic therapy
• Individuals with conditions that contraindicate the application of photodynamic therapy in the oral cavity (e.g., severe intolerance to light exposure or topical agents)
• Participants currently undergoing other experimental treatments that may interfere with the study outcomes

Sponsors & Collaborators

• Universidade Ceuma: lead

Study Sites (1)

Rua Perdizes, Quadra 35, n. 27/805, Jardim Renascença

São Luís, Maranhão, 65075340, Brazil

Location

Related Publications (1)

• Rocha BA, Melo Filho MR, Simoes A. Antimicrobial Photodynamic Therapy to treat chemotherapy-induced oral lesions: Report of three cases. Photodiagnosis Photodyn Ther. 2016 Mar;13:350-352. doi: 10.1016/j.pdpdt.2015.07.172. Epub 2015 Jul 26.

  PMID: 26222604 BACKGROUND

MeSH Terms

Conditions

Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa Acquisita

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Collagen Diseases; Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: N/D
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doutor

Model Details: This study follows a single-arm interventional clinical design aimed at evaluating the effects of curcumin-mediated photodynamic therapy (PDT) on oral lesions in patients with epidermolysis bullosa (EB). All eligible participants with EB will receive the intervention, consisting of topical application of 0.1% curcumin gel followed by blue LED irradiation (440-480 nm) over three consecutive days. Outcomes will be assessed longitudinally within the same group, allowing intra-subject comparison before and after treatment. A matched non-EB control group will be included exclusively for comparative analysis of salivary biomarkers and will not receive the intervention. The study is non-randomized and open-label, with a prospective approach focusing on treatment response, pain reduction, and quality of life changes over time.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: January 12, 2026
• Primary Completion: January 23, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)