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NCT01160848 · ClinicalTrials.gov registry record · Phase 2
Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients
A Phase 2 study, sponsored by Photocure.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01160848: Completed Phase 2 study, sponsored by Photocure.
NCT01160848 is a Phase 2 study that has completed, run by Photocure. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160848, a Phase 2 study, has completed, sponsored by Photocure.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Open, prospective, randomized, single-centre study in patients with moderate to severe facial acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4 inflammatory lesions, will be selected in acne-affected areas in the face. One area should be identified on each cheek and one area should be identified on the forehead. The minimum distance between the three areas should be at least 4 cm. For each patient the three areas will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before application of the Visonac cream. One of the areas cleaned with saline wipe will also be occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo fluorescence spectroscopy will be performed in the three areas before cream application, and at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence spectroscopy reading, the cream should be wiped off and the patient should protect the three areas from sunlight, prolonged, or intense light for 2 days. The study was extended with additionally 8 patients to explore the photoactive porphyrin levels over a 24 hour period: The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream application. For each patient the three areas will be randomized to Visonac 80mg left on the skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour. In vivo fluorescence spectroscopy will be performed at all three areas before cream application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream application. The exact time points may be adjusted based on the result from the previously included patients. All patients will be instructed to protect the three areas from sunlight, prolonged, or intense light for 2 days.
Primary Outcome
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Interventions
- DRUG Area cleaned with saline water and occluded with Tegaderm
- DRUG Area cleaned with saline water
- DRUG Area cleaned with Ethyl alcohol solution
- DRUG Visonac left on the skin for 24 hours in facial area one
- DRUG Visonac wiped off after one hour
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01160848 record still lists
NCT01160848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Area cleaned with saline water and occluded with Tegaderm is the first listed.
NCT01160848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160848 about?
NCT01160848 is a clinical study titled "Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients". Open, prospective, randomized, single-centre study in patients with moderate to severe facial acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4 inflammatory lesions, will be selected in acne-affected areas in the face. One area should be identified on each...
What is the current status of trial NCT01160848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-08. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01160848?
The interventions under investigation include: Area cleaned with saline water and occluded with Tegaderm (DRUG), Area cleaned with saline water (DRUG), Area cleaned with Ethyl alcohol solution (DRUG), Visonac left on the skin for 24 hours in facial area one (DRUG), Visonac wiped off after one hour (DRUG).
Who is sponsoring clinical trial NCT01160848?
This trial is sponsored by Photocure, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01160848's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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