Assessing the effectiveness of ENDOR combination therapy in atopic dermatitis (eczema) and psoriasis patients
Combination of ENDOR Dermatitis Care Oral Capsules and a Topical ENDOR Cream Therapy to Treat Moderate Atopic Dermatitis and Psoriasis in Participants Aged 9 – 65 years: A Randomised, Double-Blind Placebo-Controlled Trial.
GNP Australia
60 participants
Jan 13, 2020
Interventional
Conditions
Summary
ENDOR combination therapy is a natural alternative to steroid use, in the treatment of eczema and psoriasis. ENDOR Dermatitis Care Capsules contain multivitamins and other natural anti-inflammatory ingredients such as curcumin and ENDOR 3.5 cream is a soothing, moisturizing cream. This clinical trial will assess the effectiveness and safety of ENDOR Combination Therapy (ENDOR 3.5 cream and ENDOR Dermatitis Care Capsules) in treating moderate atopic dermatitis or psoriasis. A total of 60 participants will be recruited, and will use ENDOR Combination Therapy for sixty days. During the study, site personnel will assess their skin conditions, take progress photographs and administer questionnaires to assess quality of life. 20% of participants will be allocated to the placebo arm, and will be receiving dummy treatment. These patients will be offered the opportunity to trial ENDOR Combination Therapy at the end of the study if interested.
Eligibility
Inclusion Criteria7
- Males or females aged 9 – 65 years at the time of screening.
- Individuals diagnosed with atopic dermatitis as per Hanifin and Rajka criteria and confirmed by a dermatologist, or psoriasis (diagnosed by a qualified dermatologist)
- Individuals with moderate atopic dermatitis (defined as EASI 10 – 16) or moderate psoriasis (defined as PASI 10-16).
- 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).
- Be able to provide written informed consent prior to the performance of any study specific procedures.
- 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.
- Willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion Criteria23
- Participants with >25% affected body surface area of atopic dermatitis or psoriasis on the face, palms or soles
- 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.
- History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
- 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.
- 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.
- 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.
- 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.
- Have major surgery planned within the trial period.
- Participants who are unable to sign consent or unable to return for all scheduled study visits.
- Patients who are currently pregnant or breast-feeding, or planning to fall pregnant/breast-feed during the trial
- 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.
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Interventions
ENDOR Combination therapy - ENDOR Dermatitis Care capsules and ENDOR 3.5 topical cream. Treatment phase dosing occurs from Day 0 up to Day 30, when participants aged 16 – 65 years old will take four capsules per day, two in the morning and two at night, and those aged 9 – 15 years take two capsules per day, one in the morning and one at night. The participants concomitantly topically apply at least 3g of the study cream, twice daily. The recommendation application amount is 2g of cream to a treatment area the size of the participants hand span. Participants will be shown the amount they need to apply at their initial study visit. There is no maximal dose for the ENDOR cream, however patients with extensive disease will not be eligible for the study (moderate severity only). After the initial 30 days, the participants enter the maintenance phase where participants aged 16- 65 years take two capsules per day, one in the morning and one at night, and participants aged 9-15 years take one capsule per day. The maintenance phase will begin at Day 30 and end on Day 60. Participants will continue to apply the ENDOR cream to affected areas, using 2g/area the size of the participants hand span, until the lesions resolve. Participants will be required to return all used and unused medication to the trial site for compliance monitoring.
Locations(1)
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ACTRN12619001536156