Table 1.

Outcomes and descriptions.

Outcomes		Inclusiona	PDT 1b	PDT 2c	Evaluation M3d	PDT 3e	PDT 4f	Evaluation M6g
Primary outcomes
	Evaluation of lesion area and aspect by investigator and a blinded independent committee of physicians from standardized photographs taken during inclusion	x			x			x
	Disease control rate (stable, partial, complete response)				x			x
	Local tolerance (adverse event, serious adverse event, concomitant treatments)		x	x	x	x	x	x
Secondary outcomes
	Evaluation of pain: visual analog scale graduated from 0 (no pain) to 10 (unbearable pain)		x	x		x	x
	Severity of erythema (chromametry)	x			x			x
	Quality of life and satisfaction (DLQIh, FSFIi, SF-36j, and HADSk)	x			x			x
	Satisfaction questionnaire							x
	Presence of Paget cells: Positive/negative biopsy	x			x			x
	Presence of protoporphyrin IX in selected lesion (fluorescence detection)		x	x		x	x

^aInclusion: D0.

^bPDT 1: photodynamic therapy within 30 days or at D0.

^cPDT 2: photodynamic therapy 15 days after PDT 1 (±2 days).

^dEvaluation M3: D0 + 3 months (± 7 days).

^ePDT 3 (optional): photodynamic therapy within 30 days after M3.

^fPDT 4 (optional): photodynamic therapy 15 days after PDT 3 (±2 days).

^gEvaluation M6: D0 + 6 months (±7 days).

^hDLQI: Dermatology Life Quality Index.

ⁱFSFI: Female Sexual Functioning Index.

^jSF-36: 36-item Short Form Health Survey.

^kHADS: Hospital Anxiety and Depression Scale.