Photopill Treatment in Healthy Volunteers (Photopill)
|ClinicalTrials.gov Identifier: NCT01702662|
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : December 11, 2012
Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.
Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.
Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerated Mucosa of Colon||Device: Photopill treatment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Photopill treatment
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
Device: Photopill treatment
2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
- Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability [ Time Frame: During Study period: day 0-14 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702662
|Academic Medical Center Amsterdam, department of Gastroenterology|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Principal Investigator:||Geert D'Haens, Prof.dr||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|