NCT05080764Phase 2Completed

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-08-22Actual

Enrollment · participants120Actual

Source updated2026-07-08Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-08 · 3 fields changed

Participant count type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit

− Previous value

count: 126; type: ESTIMATED

+ Updated value

count: 120; type: ACTUAL

Recruitment status

Recorded edit

− Previous value

Active not recruiting

+ Updated value

Completed

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Study details

Conditions studied

Acne Vulgaris

Treatments or interventions studied

Not recorded

Primary outcomes · main study measures

Read the study measures

measure: Relative change in the number of inflammatory lesions (relative change from baseline) 8 weeks after the last PDT as assessed by investigator.; description: Outcome 1 is the relative change in the number of inflammatory lesions at the final visit with respect to baseline as assessed by the investigator.; timeFrame: 8 weeks after the last PDT; measure: Treatment success defined by a minimum improvement of the modified investigator global assessment (mIGA) score by at least 2 assessed 8 weeks after the last PDT and resulting in an mIGA score of 0 (clear) or 1 (almost clear).; description: Treatment success is defined as a minimum improvement of the mIGA score by at least 2 and resulting in an mIGA score of 0 (clear) or 1 (almost clear).; timeFrame: 8 weeks after the last PDT

History coverage

Imported research includes version dates later than the current official API record (2026-07-08). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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