Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Change in Physical Global Assessment (PGA) after topical application of Sirolimus for 12 weeks	12 weeks	The primary outcome will consist in the evaluation of global severity of the LMLM using PGA (Physical Global Assessment) 0 to 5 score, by three independent blinded experts, on monthly standardized photographs. A 1-point improvement versus baseline in PGA scale would already have a clinical relevance. Our primary analysis will focus on change in PGA after topical application of Sirolimus for 12 weeks
Secondary	Investigator-assessed PGA	at weeks 0, 4, 8, 12, 16, 20 and 24	Investigator-assessed PGA (Physical Global Assessment)
Secondary	Assessment by the patient regarding severity of oozing, bleeding, sialorrhea, eating impairment, taste modification, aesthetic impairment, pain and global discomfort,	at weeks 0, 4, 8, 12, 16, 20 and 24.	Assessment by the patient regarding severity of oozing, bleeding, sialorrhea, eating impairment, taste modification, aesthetic impairment, pain and global discomfort, each using a numeric scale from 0 to 10 (0: clear, 10: very severe), at weeks 0, 4, 8, 12, 16, 20 and 24
Secondary	Global evolution assessed by the patient	at weeks 4, 8, 12, 16, 20 and 24.	Global evolution assessed by the patient from -10 to 10 (-10 = severe worsening, 0 = no change, 10 = complete recovery), at weeks 4, 8, 12, 16, 20 and 24.
Secondary	Global Quality of life assessment	at baseline, at time of switch to the intervention (either week 0, week 4, week 8 or week 12) and week 24.	(DLQI or children's DLQI for minors aged 5 to 16), at baseline, time of switch to treatment and week 24.
Secondary	Measurements of the lesion	at baseline, at time of switch to the intervention (either week 0, week 4, week 8 or week 12) and week 24.	by the investigator, at baseline, time of switch to treatment and week 24.
Secondary	Time to obtain optimal results	up to 24 weeks	i.e. time from switch to treatment to time reaching the minimal PGA score
Secondary	Assessment of tolerance of topical sirolimus:	from the switch to intervention up to the end of the study, i.e a maximum of 24 weeks.	record of local side effects at each visit after the patient has crossed over to the intervention, up to 24 weeks
Secondary	General side effects	rom the switch to intervention up to the end of the study, i.e a maximum of 24 weeks.	Follow-up of general side effects
Secondary	Assessment of sirolimus blood passage	after 4 weeks of treatment, then 8 weeks, then every 8 weeks until week 24	by measuring residual sirolimus blood concentration: after 4 weeks of treatment, then 8 weeks, then every 8 weeks until week 24
Secondary	Evaluation of biological safety	after 8,16 and up to 24 weeks	Number of participants with at least one biological abnormality treatment-related adverse events as assessed by CTCAE v4.0

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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