Status:
COMPLETED
A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Skin Diseases
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE, MAINTENANCE and FOLLOW-UP. Subjects will complete the SCREENING phase to check the eligibility within 7 day...
Detailed Description
Background Atopic dermatitis (AD) is a chronic relapsing skin disease caused by the intervention of plural unspecific stimulation or specific allergens accompanied with cutaneous physiologic dysfuncti...
Eligibility Criteria
Inclusion
- Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the package insert of CUTIVATE and PHYSIOGEL Lotion.
- Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects eligible for enrolment in the study must meet all of the following criteria:
- male or female patients age between 1 to 18 years old (including 1 year and excluding 18 years old);
- Diagnose atopic dermatitis according to criteria of Williams;
- Mild to moderate AD on the head/neck, trunk, upper limbs or lower limbs and PSGA scores 2-3;
- The informed consent must be signed before any study specific tests or procedures are initiated;
- Subjects eligible for enrolment in the MAINTENANCE phase of the study must meet all of the following criteria:
- Achieve treatment success after receiving Fluticasone propionate 0.05% cream twice daily up to 4 weeks in ACUTE phase
Exclusion
- Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Acute phase:
- Dermatitis of only the face, feet or hands;
- The involved area has exceeded 10% of the whole body area;
- Diagnosed contact dermatitis at predilection sites of AD;
- Atrophy, telangiectasia, extensive scarring lesions in the area or areas to be treated;
- Had topical therapies including but not limit to calcineurin inhibitors (topical tacrolimus or topical pimecrolimus), corticosteroids, antihistamines within 14 days prior to screening;
- Has accepted nonsteroidal immunosuppressants (eg cyclosporine, methotrexate), or ultraviolet light treatments including ultraviolet-A and ultraviolet-B, or systemic corticosteroids regardless administration by oral, intramuscular, or intravenous within 4 weeks prior to screening;
- Pregnant or breast-feeding. Women of Childbearing Potential (WOCBP) with a positive urine pregnancy test performed within 7 days before the start of treatment;
- Has immunocompromised disease (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (including basal cell carcinoma, squamous cell carcinoma, melanoma);
- Has open skin infections (bacterial, viral or fungal) if at the application site;
- Has head lice or scabies;
- Present with clinical conditions other than AD that may interfere with the valuation (e.g. generalized erythrodema, toxicoderma, acne, Netherton's Syndrome, psoriasis);
- Require systemic therapy for the treatment of atopic dermatitis, or had systemic therapy including but not limit to antihistamines within 14 days prior to screening;
- Has accepted any experimental or investigational drug or therapy within 6 weeks prior to screening;
- Has known hypersensitivity to Fluticasone Propionate 0.05% cream, or PHYSIOGEL lotion, or relate drugs;
- Non-compliance with general medical treatment, or are known to miss appointments, or don't intend to comply with the protocol for the duration of the study;
- Drug abuse, mental dysfunction, or other factors limiting the subject's ability to cooperate fully with study-related procedures;
- Know to be unreliable or may be unable to complete the study;
- Any condition or prior/present treatment that would render the subject not eligible for the study;
- Maintenance phase:
- Accepted topic therapies other than Fluticasone propionate 0.05% cream and emollients during the ACUTE phase;
- Has active skin infection (bacterial, viral or fungal).
Key Trial Info
Start Date :
December 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2015
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01915914
Start Date
December 23 2013
End Date
February 15 2015
Last Update
October 12 2018
Active Locations (4)
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1
GSK Investigational Site
Shenzhen, Guangdong, China, 518038
2
GSK Investigational Site
Changsha, Hunan, China, 410007
3
GSK Investigational Site
Beijing, China
4
GSK Investigational Site
Shanghai, China, 200092