Dermatologic DiseaseNCT05033574
The State of Sexual Development in Children With Inherited Epidermolysis Bullosa
An observational study of Dermatologic Disease and Epidermolysis Bullosa, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.
Trial summary
The aim of the study is to determine the state of sexual development in patients with inherited epidermolysis bullosa; the study is planned to include boys and girls aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, Kindler syndrome. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Dermatologic Disease, Epidermolysis Bullosa, Epidermolysis Bullosa Simplex
- What is being tested?
- Biochemical study of hormone levels, Ultrasound examination and Radiography of the hands
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 8 Dec 2020to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female patients from 8 to 18 years of age with an established diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, Kindler syndrome.
Who may be able to join
- 1. Male and female patients from 8 to 18 years of age with an established diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, Kindler syndrome.
Who cannot join
- Hypergonadotropic hypogonadism;
- previous treatment with sex steroids or gonadotropins;
- the presence of endocrine diseases (hypothyroidism, hypercorticism, hyperprolactinemia, diabetes mellitus);
- the presence of chronic somatic diseases that are not complications of inherited epidermolysis bullosa (bronchopulmonary diseases, cardiovascular diseases, diseases of the urinary system, diseases of the gastrointestinal tract).
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Center for Children's Health
Moscow, 119296
About this study
The aim of the study is to determine the state of sexual development in patients with inherited epidermolysis bullosa; the study is planned to include boys and girls aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, Kindler syndrome.
Read the detailed description
Determination of sexual development in children with various types of inherited epidermolysis bullosa using clinical, laboratory and instrumental methods for diagnosing the condition.
Phenotyping of patients with inherited epidermolysis bullosa, taking into account their physical and sexual development, indicators of self-attitude and socialization.
Development of algorithms for individual care for patients with inherited epidermolysis bullosa, including an assessment of the psychological state at different age stages (primary school and adolescence), the volume and form of psychological and pedagogical assistance in complex rehabilitation.
- Conditions
- Dermatologic Disease, Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional, Kindler Syndrome
- Being tested
- Biochemical study of hormone levels, Ultrasound examination, Radiography of the hands, Consultation of a medical psychologist
- Keywords
- inherited epidermolisys bullosa, epidermolisys bullosa, epidermolisys bullosa simplex, epidermolisys bullosa junctional, epidermolisys bullosa dystrophic, Kindler syndrome, puberty, sexual development, epidermolysis bullosa, congenital epidermolysis bullosa
- Medical subject headings
- Skin Diseases, Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional, Poikiloderma of Kindler, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical study of hormone levelsDiagnostic test
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examinationDiagnostic test
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the handsRadiation
Determination of bone age using radiography of the hands
Consultation of a medical psychologistBehavioural
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
| Study group | Role | What they receive |
|---|---|---|
| Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex | Female patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa | Female patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic | Female patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome | Female patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex | Male patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa | Male patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic | Male patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist | |
| Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa | Male patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. Receives: Diagnostic Test: Biochemical study of hormone levels; Diagnostic Test: Ultrasound examination; Radiation: Radiography of the hands; Behavioral: Consultation of a medical psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the state of sexual development of children with various types of inherited epidermolysis bullosa using the Tanner scale
The endocrinologist's assessment of pubertal development in boys and girls using the Tanner Scale
Measured: 1 day
Determination of the state of functional activity of the sex glands in children with various types of inherited epidermplysis bullosa by the method of biochemical study of the level of sex hormones
Determination of serum levels of sex hormones in patients (luteinizing hormone, follicle-stimulating hormone, estradiol, total testosterone).
Measured: 1 day
Determination of additional hormonal indicators
Determination of blood levels of adrenocorticotropic hormone, cortisol, dehydroepiandrosterone-sulfate, 17-hydroxyprogesterone, prolactin, insulin, thyrotropic hormone, triiodothyronine and thyroxine.
Measured: 1 day
Functional development and morphometric parameters of the genital glands in children with various types of inherited epidermolysis bullosa by ultrasound diagnostics
Ultrasound examination of pelvic organs in girls and scrotal organs in boys to determine morphometric indices.
Measured: 1 day
The state of bone age in children with various types of inherited epidermolysis bullosa using X-ray examination of the hands
Determination of bone and chronological age correspondence by radiography of the left wrist joint.
Measured: 1 day
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the Pearce-Harris scale
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the Peirce-Harris scale
Measured: 1 day
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the personality drawing technique of K. Machover
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the personality drawing technique of K. Machover
Measured: 1 day
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the T. Aachenbach questionnaire
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the T. Aachenbach questionnaire
Measured: 1 day
Determination of the level of intellectual development in children with various types of inherited epidermolysis bullosa using D. Wexler's test
Determination of the level of intellectual development and its components (verbal and non-verbal intelligence) in children with various types of inherited epidermolysis bullosa
Measured: 1 day
Determination of the severity of the course of the disease in children with various types of inherited epidermolysis bullosa using EBDASI
Determination of the severity of the course of the disease in children with various types of inherited epidermolysis bullosa using Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start8 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Children's Health, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033574
- Sponsor's protocol ID
- 6
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The State of Sexual Development in Children With Inherited Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT05033574
- Acronym / sponsor ID
- 6
- Conditions
- Dermatologic Disease, Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional, Kindler Syndrome
- Keywords
- inherited epidermolisys bullosa, epidermolisys bullosa, epidermolisys bullosa simplex, epidermolisys bullosa junctional, epidermolisys bullosa dystrophic, Kindler syndrome, puberty, sexual development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Medical Research Center for Children's Health, Russian FederationOther government
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the state of sexual development in patients with inherited epidermolysis bullosa; the study is planned to include boys and girls aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, Kindler syndrome.
Detailed description
Determination of sexual development in children with various types of inherited epidermolysis bullosa using clinical, laboratory and instrumental methods for diagnosing the condition.
Phenotyping of patients with inherited epidermolysis bullosa, taking into account their physical and sexual development, indicators of self-attitude and socialization.
Development of algorithms for individual care for patients with inherited epidermolysis bullosa, including an assessment of the psychological state at different age stages (primary school and adolescence), the volume and form of psychological and pedagogical assistance in complex rehabilitation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistFemale patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistFemale patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistFemale patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistFemale patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistMale patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistMale patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistMale patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
| Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa | – | Diagnostic Test: Biochemical study of hormone levels, Diagnostic Test: Ultrasound examination, Radiation: Radiography of the hands, Behavioral: Consultation of a medical psychologistMale patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female patients from 8 to 18 years of age with an established diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, Kindler syndrome.
Key inclusion criteria (1 listed)
- 1. Male and female patients from 8 to 18 years of age with an established diagnosis of epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, Kindler syndrome.
Key exclusion criteria (4 listed)
- Hypergonadotropic hypogonadism;
- previous treatment with sex steroids or gonadotropins;
- the presence of endocrine diseases (hypothyroidism, hypercorticism, hyperprolactinemia, diabetes mellitus);
- the presence of chronic somatic diseases that are not complications of inherited epidermolysis bullosa (bronchopulmonary diseases, cardiovascular diseases, diseases of the urinary system, diseases of the gastrointestinal tract).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemical study of hormone levelsBiochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr | Diagnostic test | Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa, Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa |
| Ultrasound examinationUltrasound examination of the pelvic organs in girls and the scrotum organs in boys | Diagnostic test | Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa, Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa |
| Radiography of the handsDetermination of bone age using radiography of the hands | Radiation | Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa, Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa |
| Consultation of a medical psychologistConsultation with a medical psychologist to determine the patient's psychological condition and level of intelligence | Behavioural | Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa, Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic, Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex, Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa |
Primary outcome
Assessment of the state of sexual development of children with various types of inherited epidermolysis bullosa using the Tanner scale
Time frame: 1 day
The endocrinologist's assessment of pubertal development in boys and girls using the Tanner Scale
Determination of the state of functional activity of the sex glands in children with various types of inherited epidermplysis bullosa by the method of biochemical study of the level of sex hormones
Time frame: 1 day
Determination of serum levels of sex hormones in patients (luteinizing hormone, follicle-stimulating hormone, estradiol, total testosterone).
Determination of additional hormonal indicators
Time frame: 1 day
Determination of blood levels of adrenocorticotropic hormone, cortisol, dehydroepiandrosterone-sulfate, 17-hydroxyprogesterone, prolactin, insulin, thyrotropic hormone, triiodothyronine and thyroxine.
Functional development and morphometric parameters of the genital glands in children with various types of inherited epidermolysis bullosa by ultrasound diagnostics
Time frame: 1 day
Ultrasound examination of pelvic organs in girls and scrotal organs in boys to determine morphometric indices.
The state of bone age in children with various types of inherited epidermolysis bullosa using X-ray examination of the hands
Time frame: 1 day
Determination of bone and chronological age correspondence by radiography of the left wrist joint.
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the Pearce-Harris scale
Time frame: 1 day
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the Peirce-Harris scale
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the personality drawing technique of K. Machover
Time frame: 1 day
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the personality drawing technique of K. Machover
Determination of the psychological state of children with various types of inherited epidermolysis bullosa using the T. Aachenbach questionnaire
Time frame: 1 day
Determination of the relationship between self-esteem and gender development in children with different types of hereditary epidermolysis bullosa using the T. Aachenbach questionnaire
Determination of the level of intellectual development in children with various types of inherited epidermolysis bullosa using D. Wexler's test
Time frame: 1 day
Determination of the level of intellectual development and its components (verbal and non-verbal intelligence) in children with various types of inherited epidermolysis bullosa
Determination of the severity of the course of the disease in children with various types of inherited epidermolysis bullosa using EBDASI
Time frame: 1 day
Determination of the severity of the course of the disease in children with various types of inherited epidermolysis bullosa using Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Disease and Epidermolysis Bullosa, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the state of sexual development of children with various types of inherited epidermolysis bullosa using the Tanner scale (time frame: 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.