Last updated: 11/27/2024 13:00:23
Modelling of safety of use of clobetasol propionate in 1-12 years children
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Model-Based Evaluation of the Effects of Topical Clobetasol Propionate use on Cortisol Levels and Developmental Growth in Children aged 1 to 12 years
Trial description: This analysis will evaluate the safety of topical clobetasol in children aged 1 to 12 years. This evaluation will provide the basis for further assessment of the overall benefit-risk balance (i.e., anti-inflammatory effects versus cortisol suppression and growth retardation) taking into account the currently approved and recommended use in children aged 1 to 12 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Systemic clobetasol exposure as predicted by the Physiologically-based pharmacokinetic (PBPK) model
Timeframe: Up to 240 days
Predicted effect of clobetasol on cortisol suppression
Timeframe: Up to 240 days
Predicted effect on growth velocity after use of clobetasol based on current dosing recommendations
Timeframe: Up to 240 days
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-30-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dermatitis, Atopic
Product
clobetasol
Collaborators
Not applicable
Study date(s)
March 2023 to November 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
1 - 12 Years
Accepts healthy volunteers
Yes
- Participants treated with clobetasol propionate cream or ointment for eczema or psoriasis.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Participants treated with clobetasol propionate cream or ointment for eczema or psoriasis.
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2023-30-11
Actual study completion date
2023-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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