Reducing light sensitivity after photodynamic therapy

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: Metvix Product Name: Metvix Product Code: 32850 Pharmaceutical Form: Cream CONDITION: Sun damage skin ; MedDRA version: 14.1 Level: LLT Classification code 10063071 Term: Solar elastosis System Organ Class: 10040785 ‐ Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: Reducing light sensitivity after photodynamic therapy using sun protection factors Primary end point(s): skin redness after treatment Secondary Objective: PpIX fluorescence and pain during therapy Timepoint(s) of evaluation of this end point: 1‐2 days after treatment SECONDARY OUTCOME: Secondary end point(s): Ppx fluorescence ; pain Timepoint(s) of evaluation of this end point: during and 1‐2 days after treatment INCLUSION CRITERIA: sun damage skin above age of 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Epistemonikos ID: f07a047555b593b03ca7e7d7816357b8234ef4cd
First added on: Aug 22, 2024