X-linked hypohidrotic ectodermal dysplasia (XLHED)
Conditions
Brief summary
Mean sweat volume collected on both forearms after local stimulation with pilocarpine (pilocarpine-induced sweating).
Detailed description
Mean sweat pore density (number/cm2) determined by direct visualization with a VivaScope® at 6 months of age (V8) at 2 different sites on the soles of the feet, Dental development evaluated by the number of erupted teeth and tooth buds (palpable alveolar structures in the alveolar ridge) as determined by oral examination at 6 months of age (V8), Mean sweat volume on both forearms measured from a pilocarpineinduced sweat test (at other timepoints than 6 months)., Sweat pore density (at other timepoints than 6 months)., Dentition (at other timepoints than 6 months)., Dry eye, Salivation assessment, Number of XLHED related hospitalizations, Assessment of eczema, Safety and tolerability assessments, Health-related quality of life assessments
Interventions
DRUGER004
Sponsors
Pierre Fabre Medicament, Fondation EspeRare
Eligibility
Sex/Gender
Male
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean sweat volume collected on both forearms after local stimulation with pilocarpine (pilocarpine-induced sweating). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean sweat pore density (number/cm2) determined by direct visualization with a VivaScope® at 6 months of age (V8) at 2 different sites on the soles of the feet, Dental development evaluated by the number of erupted teeth and tooth buds (palpable alveolar structures in the alveolar ridge) as determined by oral examination at 6 months of age (V8), Mean sweat volume on both forearms measured from a pilocarpineinduced sweat test (at other timepoints than 6 months)., Sweat pore density (at other timepoints than 6 months)., Dentition (at other timepoints than 6 months)., Dry eye, Salivation assessment, Number of XLHED related hospitalizations, Assessment of eczema, Safety and tolerability assessments, Health-related quality of life assessments | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed