Clinical trials: X-linked Hypohidrotic Ectodermal Dysplasia
X-linked Hypohidrotic Ectodermal Dysplasia
Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia
X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse hair and eyebrows, and oligodontia.
- Trial name
- NCT01308333
- Where
- Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University Hospital Erlangen
Hypohidrotic Ectodermal Dysplasia
Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia: Intrafamilial Variation
This study in affected Hypohidrotic Ectodermal Dysplasia (HED) males and unaffected male controls, age 1 year and up, will use minimally invasive devices to image sweat ducts in intact skin, to measure stimulated sweat rate, and…
- Trial name
- NCT01386775
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
X-linked Hypohidrotic Ectodermal Dysplasia, Hypohidrotic Ectodermal Dysplasia
Phenotypic and Genetic Properties in Males at Risk for X-linked Hypohidrotic Ectodermal Dysplasia: Evaluation of an Early Diagnosis Technology and Tests to Assess Nutritional Status
The investigators propose to obtain facial photographs for use in testing a computer algorithm that recognizes males at high risk for Hypohidrotic Ectodermal Dysplasia (XLHED).
- Trial name
- ECP-013 (NCT01629940)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
Hypohidrotic Ectodermal Dysplasia, X-Linked Hypohidrotic Ectodermal Dysplasia
Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype
This study is being done to collect information about people who have or may have Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia (XLHED).
- Trial name
- ECP-006 (NCT01398397)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Edimer Pharmaceuticals
X-linked Hypohidrotic Ectodermal Dysplasia
Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002
The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned.
- Trial name
- ECP-002e (NCT01992289)
- Testing
- EDI200
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Edimer Pharmaceuticals
X-Linked Hypohidrotic Ectodermal Dysplasia
Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male newborns in the first two weeks of life.
- Trial name
- ECP-002 (NCT01775462)
- Testing
- EDI200
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 6 people
- Sponsor
- Edimer Pharmaceuticals
Hypohidrotic Ectodermal Dysplasia, X-Linked Hypohidrotic Ectodermal Dysplasia
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) Carrier Outlook Toward Reproduction Survey
In this survey of X-Lined Hypohidrotic Ectodermal Dysplasia (XLHED) carrier females, Edimer proposes to review responses to an XLHED Carrier Outlook toward Reproduction Survey in order to understand attitudes toward reproduction…
- Trial name
- X-CORS (NCT01398813)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Edimer Pharmaceuticals
Hypohidrotic Ectodermal Dysplasia
Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls.
- Trial name
- DEH-Somno (NCT05378932)
- Testing
- Actigraphy, Recording of proximal and distal skin temperature and temperature of the bedroom, Questionnaires assessing subjective sleep quality
- Where
- France
- Volunteers
- 22 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
Characteristics and Impacts of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) in Boys: An Observational International Study
This is an observational, multicentre, international study over a 2-year follow-up period. The aim of this study is to understand how XLHED affects the lives of young male patients and their families over time.
- Trial name
- EdeReaLife (NCT07096206)
- Where
- 2 sites in France, Germany
- Volunteers
- 27 people
- Sponsor
- Pierre Fabre Medicament
Hypohidrotic Ectodermal Dysplasia
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia - A
The overall purpose of this study is to learn more about Hypohidrotic Ectodermal Dysplasia (HED) and to help in identifying treatment opportunities.
- Trial name
- NCT01293565
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
Hypohidrotic Ectodermal Dysplasia
Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia
Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack of sweat glands, sparse hair, and missing or malformed teeth.
- Trial name
- NCT01109290
- Where
- Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University Hospital Erlangen
Ectodermal Dysplasia
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia
To characterize skin properties in male subjects with HED
- Trial name
- NCT01108770
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
X-linked Hypohidrotic Ectodermal Dysplasia, Hypohidrotic Ectodermal Dysplasia
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012)
The study proposes to enroll male subjects affected by Hypohidrotic Ectodermal Dysplasia (XLHED). The sweat duct images will be acquired with a CE marked skin-imaging device and the sweat rate will be measured using a CE marked…
- Trial name
- ECP-012 (NCT01629927)
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
X Linked Hypohidrotic Ectodermal Dysplasia
Phenotypic Properties in Individuals Affected With XLHED
The current study design incorporates two previously developed, non-invasive approaches to characterize the phenotype of individuals affected with XLHED.
- Trial name
- ECP-014 (NCT01871714)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
X-Linked Hypohidrotic Ectodermal Dysplasia
Natural History and Outcomes in X-Linked Hypohidrotic Ectodermal Dysplasia
The proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of XLHED based on genetic testing and who have not received an investigational study drug.
- Trial name
- ECP-015 (NCT02099552)
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 150 people
- Sponsor
- Edimer Pharmaceuticals
X-Linked Hypohidrotic Ectodermal Dysplasia
Sweat Duct Imaging in Mother/Newborn Dyads
The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.
- Trial name
- NCT01342133
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Edimer Pharmaceuticals
X-linked Hypohidrotic Ectodermal Dysplasia
A Phase 1, Open-label, Multicenter, Safety and Pharmacokinetic Study of EDI200
Following discussions with the FDA, a Phase 1 safety study is being initiated in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)-affected adults to develop safety and exposure data for EDI200 in anticipation of dosing…
- Trial name
- NCT01564225
- Testing
- EDI200
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Edimer Pharmaceuticals
Hypohidrotic Ectodermal Dysplasia
Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences
Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects…
- Trial name
- PEDCOVID-19 (NCT04741412)
- Where
- Germany
- Volunteers
- 231 people
- Sponsor
- University Hospital Erlangen
X-Linked Hypohidrotic Ectodermal Dysplasia, Exercise-induced Rise of Body Temperature
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia
Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment.
- Trial name
- NCT01135888
- Testing
- Skin cooling devices
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Hospital Erlangen
XLHED
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED
The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers.
- Trial name
- NCT03912792
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Dermelix Biotherapeutics, LLC.