Assessing the effectiveness of ENDOR combination therapy in atopic dermatitis (eczema) and psoriasis patients

Phase 4

• Conditions: psoriasis; atopic dermatitis (eczema); Skin - Dermatological conditions

• Registration Number: ACTRN12619001536156
• Lead Sponsor: GNP Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-07
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Males or females aged 9 – 65 years at the time of screening.
2.Individuals diagnosed with atopic dermatitis as per Hanifin and Rajka criteria and confirmed by a dermatologist, or psoriasis (diagnosed by a qualified dermatologist)
3.Individuals with moderate atopic dermatitis (defined as EASI 10 – 16) or moderate psoriasis (defined as PASI 10-16).
4.Have a target lesion of atopic dermatitis or psoriasis, measuring between 25 cm2 and 70 cm2 within an area of 130 cm2 (based on diagnosis by a suitably qualified Investigator).
5.Be able to provide written informed consent prior to the performance of any study specific procedures.
6.Duration of atopic dermatitis or psoriasis of at least six months, with stable disease in both extent and severity, for at least two weeks prior to the commencement of study treatment.
7.Willing and able to comply with all study assessments and adhere to the protocol schedule.

Exclusion Criteria

1.Participants with >25% affected body surface area of atopic dermatitis or psoriasis on the face, palms or soles
2.Participants with any skin condition other than atopic dermatitis or psoriasis; in particular cutaneous infections, significant sun damage or an inherited skin disorder, that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
3.History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
4.Treatment with any of the following within 4 weeks prior to the commencement of study treatment or during the study:
a.Systemic retinoids
b. Oral immunosuppressant medications such as methotrexate, cyclosporine, azathioprine, thioguanineprednisone, prednisolone, hydroxyurea, or mycophenolate mofetil
b.Oral or topical antibiotics
c.Phototherapy or photochemotherapy
d.High potency topical corticosteroids
e.Alternative medicine treatments
f.Significant sun exposure or tanning bed use
g.Any other therapy that in the opinion of the Investigator could modify disease activity.
5.Treatment with any of the following within 2 weeks prior to commencement of study treatment and during the study:
a.Weak to moderate potency topical corticosteroids
b.Topical retinoids
c.Topical keratolytics, coal tar or dithranol
d.Any other topical agent that in the opinion of the Investigator could modify disease activity.
6.Have received any investigational research agent or therapeutic biologic within 30 days or five half-lives (whichever is longer) prior to the first dose of IP.
7.Have clinical signs of active infection and/or a temperature of >38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator.
8.Have major surgery planned within the trial period.
9.Participants who are unable to sign consent or unable to return for all scheduled study visits.
10.Patients who are currently pregnant or breast-feeding, or planning to fall pregnant/breast-feed during the trial
11.Has any condition that, in the opinion of the Investigator, would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in local eczema area and severity index (L-EASI) or psoriasis area and severity index (PASI)[Day 60]

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in Investigator's Global Assessment (IGA) score for psoriasis or atopic dermatitis [Day 30 and Day 60];Percentage change from baseline in local pruritus score, assessed using a visual analogue scale (VAS)<br>[Day 30 and Day 60];Adverse events - using patient self reports, local skin irritation assessment and general clinical examination <br><br>Potential AEs - irritation at application site and potential flare of atopic dermatitis and psoriasis in the placebo arm [Day 30 and 60]