atopic dermatitis MedDRA version: 18.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: 1% DGLA Cream
Product Code: DS107E
Pharmaceutical Form: Cream
INN or Proposed INN: DGLA
CAS Number: 1783-84-2
Current Sponsor code: DS107
Other descriptive name: DIHOMO-GAMMA-LINOLENIC A
Sponsors
DS Biopharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male infants aged 3-12 months. 2. Diagnosis of atopic dermatitis according to the Hanifin and Raika Criteria. 3. Patients with moderate to severe atopic dermatitis (IGA =3) 4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline. 5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator. 6. The patient's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 63 days. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results. 2. Clinically significant impairment of renal or hepatic function. 3. Clinically significant immunodeficiency. 4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0). 5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections). 6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%). 7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed. 8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer). 9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0 Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources between screening and follow-up visits. 10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 Visit (Baseline), including but not limited to emollients, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths. 11. Use of topical products containing ceramides 2 weeks prior to Day 0. 12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of alternating treatment with Locoid® Ointment (hydrocortisone butyrate 0.1%) and 1% topical DGLA formulation OD compared to Locoid® Ointment (hydrocortisone butyrate 0.1%) and vehicle OD for 1 week, followed by 8 weeks of treatment with either 1% topical DGLA formulation alone BD or vehicle alone BD in early childhood patients with moderate to severe atopic dermatitis. ;Secondary Objective: To evaluate the efficacy of DGLA cream in the improvement of clinical signs and symptoms in AD, IGA, SCORAD, EASI, BSA, improvement of quality of life, family impact, investigation of skin barrier function, days to relapse and rescue medication use.;Primary end point(s): Change in IGA from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8). And/Or Change in SCORAD from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8). ;Timepoint(s) of evaluation of this end point: IGA – Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 and SCORAD - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: IGA – Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 SCORAD - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 EASI - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 IDQOL - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 DFI - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 BSA - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 TEWL – Baseline/Day 0, Day 63, Day 91 ;Secondary end point(s): • Change in Investigators Global Assessment score (IGA) from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in SCORAD from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in EASI from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in IDQOL from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in DFI from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in BSA from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Change in the Transepidermal water loss (TEWL) from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9). • Time to rescue medicatio | — |
Countries
Ireland
Contacts
Public ContactRegulatory Affairs Department
DS Biopharma
Outcome results
None listed