Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT02865356
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Solution for the Treatment of Atopic Dermatitis
Sponsor:
Spherium Biomed
Organization:
Study Overview
Official Title:
Evaluation of SP14019-F-01 Topical Solution for the Treatment of Atopic Dermatitis. Pilot Study (CYCLATOP STUDY)
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYCLATOP
Brief Summary:
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments.
Three age cohorts of patients will be included in the study according to the following age ranges:
1. ≥18 years old (minimum 6, maximum 18 patients)
2. \>12 - 17 years old (minimum 6, maximum 18 patients)
3. \>2 - 12 years old (minimum 6, maximum 18 patients)
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
Three age cohorts of patients will be included in the study according to the following age ranges:
1. ≥18 years old (minimum 6, maximum 18 patients)
2. \>12 - 17 years old (minimum 6, maximum 18 patients)
3. \>2 - 12 years old (minimum 6, maximum 18 patients)
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
Detailed Description:
The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments. CsA plasma concentration assessments will be carried out at Visit 0 predose, and Visits 1 and 4 of the study period.
Three age cohorts of patients will be included in the study according to the following age ranges:
1. ≥18 years old (minimum 6, maximum 18 patients)
2. \>12 - 17 years old (minimum 6, maximum 18 patients)
3. \>2 - 12 years old (minimum 6, maximum 18 patients) The study will close when the total of 36 patients has been included among all age groups and the minimum number of 6 patients has been reached for each age group.
Before including paediatric population, a minimum of 6 adult patients should complete the treatment to assess the safety profile.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication (SP14019-F-01 topical solution \[5% CsA\] or SP14019-F-02 vehicle-control placebo solution). Solutions will be applied twice daily for four complete weeks (28 days) in all affected areas.
Photography will be used to record the evolution of the lesions at Visits 0 (pre-1st dose), Visits 1, 2, 3, 4 and follow-up.
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
A Steering Committee will convene periodically to maintain the quality of study conduct, and to discuss any major issues or concerns and with particular attention to some critical events which may lead to stop the recruitment. These critical events are the observation of either new unexpected signals on safety related to CsA. The Steering Committee will also evaluate the safety profile of the treatment before including paediatric population
Three age cohorts of patients will be included in the study according to the following age ranges:
1. ≥18 years old (minimum 6, maximum 18 patients)
2. \>12 - 17 years old (minimum 6, maximum 18 patients)
3. \>2 - 12 years old (minimum 6, maximum 18 patients) The study will close when the total of 36 patients has been included among all age groups and the minimum number of 6 patients has been reached for each age group.
Before including paediatric population, a minimum of 6 adult patients should complete the treatment to assess the safety profile.
A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication (SP14019-F-01 topical solution \[5% CsA\] or SP14019-F-02 vehicle-control placebo solution). Solutions will be applied twice daily for four complete weeks (28 days) in all affected areas.
Photography will be used to record the evolution of the lesions at Visits 0 (pre-1st dose), Visits 1, 2, 3, 4 and follow-up.
The main objectives of study are:
To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).
To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.
A Steering Committee will convene periodically to maintain the quality of study conduct, and to discuss any major issues or concerns and with particular attention to some critical events which may lead to stop the recruitment. These critical events are the observation of either new unexpected signals on safety related to CsA. The Steering Committee will also evaluate the safety profile of the treatment before including paediatric population
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: