CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
V-Beam laser, Candela Corp., 595 nm wavelengthdevice
Likely dose
V-Beam laser 595 nm wavelength, up to 6 sessions with 1-4 week intervals, fluence not exceeding 15 J/cm2AI-extracted
Key inclusion· 4
  • Age 15 years or older
  • Clinically-evident facial acne
  • Generally good health
  • Able to comply with protocol and attend all scheduled appointments in Ann Arbor, Michigan area
Key exclusion· 8
  • Oral retinoid (Accutane) use within 6 months
  • Systemic acne therapies (oral antibiotics) within 4 weeks
  • Topical acne therapies (retinoids, antibiotics) within 2 weeks
  • Prior microdermabrasion or superficial chemical peels at treatment sites within 2 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113425
NCT00113425Phase 2Completed

Photodynamic Therapy in the Treatment of Acne Vulgaris

University of Michigan·interventional·Posted Jun 8, 2005·Updated Oct 18, 2016

In Brief

A Phase 2 clinical trial evaluating V-Beam laser, Candela Corp., 595 nm wavelength for Acne Vulgaris. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2005
Enrollment StartAug 1, 2005
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 21.1 years ago

Interventions

V-Beam laser, Candela Corp., 595 nm wavelengthdevice

Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.