Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837615

Acronym

Photopill

Enrollment

Registered

2013-04-23

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proctitis, Ulcerative Colitis

Keywords

Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy

Brief summary

Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose. An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis. Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition. Furthermore clinical and biochemical parameters are monitored during the study.

Interventions

DEVICEPhotopill treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion criteria

* Symptomatic hemorrhoids * Pregnant or lactating females * Patients that have used any experimental treatment within 8 weeks prior to Day 0 * Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0 * Rectal therapy 2 weeks prior to Day 0

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	day 0-42	Any adverse events reported by subjects

Secondary

Measure	Time frame	Description
Inflammatory markers	day 0,14,28,42	serum CRP, serum Hb/Ht, fecal Calprotectin
Clinical Questionnaires	day 0,14,28,42	Simple Clinical Colitis Activity Index Partial Mayo score
Mucosal appearance at sigmoidoscopy	week 0,14,28.42	endoscopic disease activity Mayo score and possible damage by device

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026