Safety and Efficacy Study of DGLA Cream in Patients with Atopic Dermatitis

Conditions: Atopic Dermatitis
MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-003739-44-SE

Lead Sponsor: Dignity Sciences Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1.Clinically confirmed diagnosis of active atopic dermatitis according to Hanifin and Rajka criteria.
2.Patients with mild to moderate atopic dermatitis at screening; Rajka-Langeland score 3-7.5.
3. Patients with mild to moderate atopic dermatitis covering 2-50% of the body surface area
4.Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
5.Patients in general good health as confirmed by a physical examination and by medical history.
6.Patients who are able and willing to give signed informed consent (ICF).
7.Patient’s body mass index (BMI) is between 18 and 30 kg/m2 inclusive.
8.Female patients of child bearing potential, and female partners of male patients, must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) for the duration of the study; or agree to sexual abstinence for the duration of the study.
9.Patients who are able and willing to stop treatment for atopic dermatitis for the washout period (except emollients).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Females with positive pregnancy test at screening (Visit 1) or start of treatment/baseline (Visit 2) or lactating women.
2.Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
3.Patients with Netherton’s Syndrome.
4.Patients with clinically significant impairment of renal or hepatic function.
5.Patients with other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis, viral, bacterial and fungal skin infections).
6.Patients with a history of hypersensitivity to any substance in the IMP.
7.Patients with severe atopic dermatitis; Rajka-Langeland score 8-9.
8.Patients with a history of clinically relevant ECG abnormalities
9.Patients treated with any experimental drug within 30 days prior to start of treatment/baseline visit (Visit 2).
10.Patients who have used any of the medications and therapeutic regimens excluded from the study within 14 days prior to baseline/day 0 visit (Visit 2).
11.Patients with a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease.
12.Patients with a medical history of chronic infectious disease (HCV, HBV, HIV).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate atopic dermatitis;Secondary Objective: To assess the safety, tolerability and the bioavailability of three doses of topically applied DGLA cream, versus placebo, in patients with mild to moderate atopic dermatitis;Primary end point(s): Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo;Timepoint(s) of evaluation of this end point: 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in modified Eczema Area and Severity Index (mEASI) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14 and 21 days.<br><br>Change in Investigator’s Global Assessment (IGA) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.<br><br>Change in the patient’s VAS pruritus score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.<br><br>Change in the Patient Orientated Eczema Measure (POEM) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.<br><br>Change in the Dermatology Life Quality Index (DLQI) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.<br>;Timepoint(s) of evaluation of this end point: From screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.