Topical Solution for the Treatment of Atopic Dermatitis

NCT02865356 | Completed Phase 2

• 1 other identifier: SP14019-18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

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. 1.≥18 years old (minimum 6, maximum 18 patients)
2. 2.\>12 - 17 years old (minimum 6, maximum 18 patients)
3. 3.\>2 - 12 years old (minimum 6, maximum 18 patients)

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema; children; skin; topical; cyclosporine

Outcome Measures

Primary Outcomes (3)

• Absolute change from baseline (Day 0) of Eczema Area and Severity Index (EASI) score of the treated body area (CsA vs Vehicle control placebo)

  Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).

• Change from baseline (Day 0) of Investigator's Global Assessment (IGA) score (on a 0 to 4-point scale; CsA vs Vehicle control placebo)

  Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).

• Absolute change from baseline (Day 0) of Atopic Dermatitis Severity Index (ADSI) score (Cs vs Vehicle control placebo)

  Absolute change from Day 0 (baseline) to Day 7 (Visit 1), Day 14 (Visit 2), Day 21(Visit 3) and Day 28 (Visit 4).

Secondary Outcomes (3)

• Frequency and severity of treatment-emergent adverse events (TEAEs).

  From date of randomization (Day 0) until 6 weeks

• Frequency and severity of TEAEs leading to study drug discontinuation

  From date of randomization (Day 0) until 6 weeks

• CsA plasma concentrations

  From date of randomization (Day 0) up to 4 weeks, on day 7 and 28.

Study Arms (2)

Cyclosporine 5% Solution

EXPERIMENTAL

SP14019-F-01 Cyclosporine solution, 5%. Cyclosporine solution will be applied twice daily for four complete weeks (28 days) in all affected areas. A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication

Drug: Cyclosporine 5% solution

Placebo

PLACEBO COMPARATOR

SP14019-F-02 vehicle-control placebo solution. Vehicle-control placebo solution will be applied twice daily for four complete weeks (28 days) in all affected areas. A randomized list will be created to determine in which side of the body (left or right) the subject will apply each medication

Drug: Placebo

Interventions

Cyclosporine 5% solution DRUG

topical solution

Also known as: ciclosporin

Cyclosporine 5% Solution

Placebo DRUG

topical vehicle solution

Also known as: SP14019-F-02 Placebo

Placebo

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• \. Mild to moderate disease severity of AD defined by an IGA score of 2 or 3 at baseline (IGA scale from 0 to 4).
• \. 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).
• \. General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
• \. 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.
• \. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary).

You may not qualify if:

• \. 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:
• use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap);
• use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
• use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom);
• 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.
• \. Pregnant woman or with a positive pregnancy test or breast feeding at baseline.
• \. 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.
• \. Patients receiving phototherapy or systemic therapy for AD within 4 weeks before the first application of trial medication.
• \. Patients receiving antibiotics, topical therapy for AD within 2 weeks before the first application of trial medication.
• \. Patients taking antihistamines within 1 week before the first application of trial medication.
• \. Patients receiving radiation therapy, systemic therapy with cytostatics or biological therapy within 24 weeks before the first application of trial medication, or with previous history of malignancy (excluding basal cell carcinoma).
• \. Patients with any acute skin infection (superinfection or secondary impetiginisation).
• \. Patients with confirmed hypertension, renal disease or serious infections at screening.

Sponsors & Collaborators

• Spherium Biomed: lead
• Germans Trias i Pujol Hospital: collaborator
• Hospital del Mar: collaborator
• Hospital Sant Joan de Deu: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• Hospital Universitario La Fe: collaborator
• Hospital General Universitario de Alicante: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Hospital Universitario Virgen de la Victoria: collaborator
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator

Study Sites (9)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Cyclosporine; Solutions

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Study Officials

• Carlos Ferrándiz, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: September 1, 2016
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

ES (9)