At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 14 enrolled

Drug / intervention

Hexylaminolaevulinate cream +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02149342

NCT02149342Phase 2Completed

Compare CT.gov

Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate

Joint Authority for Päijät-Häme Social and Health Care·interventional·Posted May 29, 2014·Updated Jul 11, 2016

In Brief

A Phase 2 clinical trial evaluating Hexylaminolaevulinate cream and Methylaminolaevulinate cream for Actinic Keratoses. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsActinic Keratoses

CountriesFinland

CollaboratorsHelsinki University Central Hospital

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartMay 2014

First PostedMay 2014

Primary CompletionSep 2015

TodayJul 2026

First PostedMay 29, 2014

Enrollment StartMay 1, 2014

Primary CompletionSep 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 12.1 years ago

Interventions

Hexylaminolaevulinate creamdrug

0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)

Methylaminolaevulinate creamdrug

MAL 16% is used as photosensitizer for daylight-PDT