# Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp

> **NCT05662202** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Biofrontera Inc.** · enrollment: 172 (actual)

## Conditions studied

- Actinic Keratoses

## Interventions

- **COMBINATION_PRODUCT:** BF-200 ALA and red light LED lamp
- **COMBINATION_PRODUCT:** Vehicle and red light LED lamp

## Key facts

- **NCT ID:** NCT05662202
- **Lead sponsor:** Biofrontera Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-12-12
- **Primary completion:** 2025-09-03
- **Final completion:** 2026-06
- **Target enrollment:** 172 (ACTUAL)
- **Last updated:** 2026-04-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05662202

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05662202, "Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT05662202. Licensed CC0.

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