Atopic dermatitis MedDRA version: 18.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Cyclosporine A
Product Code: SP14019-F-01
Pharmaceutical Form: Cutaneous spray, solution
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Current Sponsor code: SP14019-F-01
Other
Sponsors
Spherium Biomed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 2 and 75 years, inclusive, at the screening visit. 2. AD diagnosis according to the Hanifin/Rajka criteria with one eczema outbreak at the screening and baseline. 3. Presence of at least two lesional areas. These areas should be at the left and right side of the body and occupying a body surface area (BSA) in each side between 0.1% and 10% of the BSA. IGA score of the two sites not differ by more than 1 point. 4. Mild to moderate disease severity of AD defined by an IGA score of 2 or 3 at baseline (IGA scale from 0 to 4). 5. Total BSA of AD involvement ? 10% in each side of the body (? 20% maximum). 6. Normal weight as defined by a Quetelet Index (Body Mass Index [BMI]: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2 (both included). 7. General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. 8. Parent?s or legal guardian?s written informed consent and child assent, if appropriate or patient?s inform consent for patients ? 18 years of age before any assessment is performed. 9. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary). Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period; Note: Estrogen based hormonal contraception may not be reliable when SP14019-F-01 topical solution is applied, therefore to be eligible for this trial, women of childbearing potential should either: a. use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap); b. use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); c. use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); d. be only non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile). Women with tubal ligation are required to use 1 non-hormonal contraceptive method. Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study. 2. A positive pregnancy test or breast feeding at screening or at baseline. 3. Any condition in the lesions that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than AD, sunburn, scars, hairy or tattooed area. 4. Patients receiving phototherapy or systemic therapy for AD within 4 weeks before the first application of trial medication. 5. Patients receiving antibiotics, topical therapy for AD within 2 weeks before the first application of trial medication. 6. Patients taking antihistamines within 1 week before the first application of trial medication. 7. Patients receiving radiation therapy, systemic therapy with cytostatics or immunosuppressive drugs within 24 weeks before the first application of trial medication, or with previous history of malignancy (excluding basal cell carcinoma). 8. Patients with any acute skin infection (superinfection or secondary impetiginisation). 9. Patients with confirmed hypertension, renal disease or serious infections at screening. 10. Any currently active allergy such as but not limited to drug allergy, food allergy or hay fever. 11. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the trial medication administered in this trial (Gantrez ES-425 [Poly(methyl vinyl ether/maleic anhydride], ethanol, Propylene glycol, Transcutol (Diethylene Glycol Monoethyl Ether), Tween 80, MCT, Triacetin). 12. Participation in an investigational drug trial within 30 days prior to the first application of trial medication. 13. Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the patient safety or compliance with trial procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.;Primary end point(s): Efficacy endpoints: - Absolute change from baseline (Visit 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo) from Visit 0 to Visit 1, Visit 2, Visit 3 and Visit 4. - Absolute change from baseline (Visit 0) of Investigator?s Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo) from Visit 0 to Visit 1, Visit 2, Visit 3 and Visit 4. - Absolute change from baseline (Visit 0) of Atopic Dermatitis severity index (ADSI) score (Cs vs Vehicle control placebo) from Visit 0 to Visit 1, Visit 2, Visit 3 and Visit 4. Safety endpoints: - Frequency and severity of treatment-emergent adverse events (TEAEs). - Frequency and severity of TEAEs leading to study drug discontinuation from Visit 0 through Visit 4. - CsA plasma concentrations;Timepoint(s) of evaluation of this end point: Timepoints are detailed in section E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As the study is exploratory, it is not necessary to classify endpoints as primary or secondary. All endpoints and timepoints have been detailed in section E.5.1.;Timepoint(s) of evaluation of this end point: As the study is exploratory, it is not necessary to classify endpoints as primary or secondary. All endpoints and timepoints have been detailed in section E.5.1. | — |
Countries
Spain
Contacts
Public ContactProject Manager
Spherium Biomed
Outcome results
None listed