Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical photodynamic therapy with methylaminolevulinate

Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical photodynamic therapy with methylaminolevulinate - Fractionated 5-ALA 20% PDT vs two stage MAL PDT in sBCC

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50578

Enrollment

162

Registered

2012-09-27

Start date

2013-08-30

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal cell carcinoma skin cancer

Interventions

- 81 patients with fractionated 5-ALA 20% PDT on the same day (2 hour free interval) - 81 patients with MAL PDT in 2 sessions (1 week interval)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Minimal age of 18 years Histological proven sBCC Primary sBCC (no previous treatment) Being able to understand instructions

Exclusion criteria

Exclusion criteria: Age under 18 years No histological proven sBCC Recurrent sBCC (previously treated) Not able to understand instructions Concomitant disease requiring systematic immunosuppressive treatment Genetic skin cancer disorders Pregnant women Breastfeeding women Porphyria Allergy for photosensitizer components

Design outcomes

Primary

Measure	Time frame
Treatment failure 5 years after treatment of sBCC with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions.	—

Secondary

Measure	Time frame
Degree of pain during treatment, side-effects of treatments, patient preferences and health care costs of treatment with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)