# Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).

> **NCT03573401** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Biofrontera Inc.** · enrollment: 187 (actual)

## Conditions studied

- Superficial Basal Cell Carcinoma

## Interventions

- **COMBINATION_PRODUCT:** Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
- **COMBINATION_PRODUCT:** Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)

## Key facts

- **NCT ID:** NCT03573401
- **Lead sponsor:** Biofrontera Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2018-09-25
- **Primary completion:** 2024-03-19
- **Final completion:** 2029-02
- **Target enrollment:** 187 (ACTUAL)
- **Last updated:** 2026-01-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03573401

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03573401, "Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03573401. Licensed CC0.

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