Clinical trial NCT03540043: Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis
Official title: 4-Week Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Safety and Efficacy Study of PUR 0110 (Thykamine™) Cream Applied Twice Daily in Mild-to-Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis Eczema
Keywords: Mild moderate atopic dermatitis
Lead sponsor: PurGenesis Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Parallel-Group, Placebo-controlled
Primary purpose: TREATMENT

Brief summary: A Phase 2, multicenter, double-blind, placebo control study evaluating the safety and efficacy of Thykamine in adult patient suffering of mild-to-moderate Atopic Dermatitis

Detailed description: 4-week Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Safety and Efficacy Study of Three Concentrations (0.05%, 0.1% and 0.25%) of PUR 0110 (Thykamine™) Cream Applied Twice Daily in Mild-to-Moderate Atopic Dermatitis.

Eligibility criteria: Inclusion criteria

The patient must meet all the following criteria to be enrolled in the study:

1. Male or female patients, aged 18 years or older at the screening visit.
2. Patients with diagnosis of AD for at least 6 months prior to Day 0 visit as defined by the criteria of Hanifin and Rajka (Acta Derm Venereol. 1980).
3. Patients with BSA ≥ 1 % and ≤ 15% at Day 0 (excluding palms, soles and scalp).
4. Patients with IGA score of 2 to 3 (mild-to-moderate) at Day 0.
5. Female patients of childbearing potential must have a negative pregnancy test (serum Beta-hCG) at the screening visit - unless they are surgically sterile (hysterectomy, bilateral oophorectomy or tubal ligation), in a menopausal state for at least a year, clinically diagnosed infertile, or have a same-sex partner or are abstinent.
6. In addition, females of childbearing potential or a male patient with a female partner must be willing to use an effective contraceptive method for at least 30 days (12 weeks for hormonal contraceptives) before Day 0 and at least 1 month after the last study drug administration. Effective contraceptive methods include:

   * Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
   * Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo Provera, Evra and Nuvaring; and
   * Intrauterine device (IUD).
7. Patients must be capable of giving informed consent and the consent must be obtained prior to any study related procedures.

Exclusion criteria

1. Patient with BSA \> 15% (excluding palms, soles and scalp).
2. Female who is pregnant or lactating or wishes to become pregnant during the study period.
3. Patient with a history of any confounding inflammatory skin diseases or any other skin disease, e.g., psoriasis, rosacea, erythroderma or ichthyosis, that could impair his/her safety during the study or interfere with the evaluation of AD.
4. Patient with spontaneously improving or rapidly deteriorating AD.
5. Patient with active allergic contact dermatitis or other non-atopic forms of dermatitis.
6. Patient with active cutaneous bacterial or viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
7. Patient with acute infections.
8. Patient with a history or presence of Netherton's syndrome, immunological deficiencies or diseases, diabetes, malignancy, psychological disorders, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders - which might cause this study to be detrimental to the patient or that may confound the study results or interfere significantly with the patient's participation in the study.
9. Patient with bleeding disorders.
10. Patient with known seropositivity for the human immunodeficiency virus or evidence of active hepatitis B or C.
11. Patient has an unstable or serious medical condition, as defined by the investigator, which might cause this study to be detrimental to the patient or that may confound the study results or interfere significantly with the patient's participation in the study.
12. Patient has a history of alcoholism or drug abuse within 12 months prior to Day 0.
13. Patient with known allergy, or history of allergic reaction, or hypersensitivity to spinach, spinach tablet, spinach powder or spinach extract; to mushrooms; or any ingredients present in PUR 0110.
14. Patient with a history of severe food allergies.
15. Patient with sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline (Day 0), which would interfere with evaluations.
16. Use within 4 weeks prior to baseline (Day 0) of oral or intravenous corticosteroids, UVA/UVB therapy, PUVA (psoralen plus ultraviolet A) therapy, tanning booths, non-prescription UV light sources, immunomodulators or immunosuppressive therapies, interferon, or cytotoxic drugs.
17. Use within 2 weeks of baseline (Day 0) of systemic antibiotics, calcipotriene or other vitamin D preparations, or retinoids.
18. Use within 2 weeks of baseline (Day 0) of oral natural health products or vitamins containing lutein.
19. Use within 1 week prior to baseline (Day 0) of antihistamines, topical antibiotics, topical corticosteroids, topical calcineurin inhibitors or other topical drug products used for treating AD. Inhaled corticosteroids for stable medical conditions are allowed.
20. Use within 24 hours prior to baseline (Day 0) of any topical product (e.g., sunscreens, lotions, creams) in the areas to be treated, except for bland emollient (moisturizer).
21. Use of an investigational agent within 4 weeks or 5 half-lives prior to Day 0 (whichever is longer).
22. Patient not willing to minimize or avoid natural and artificial sunlight exposure during treatment.

Primary outcomes:
measure: Efficacy as per investigator global assessment (IGA)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events (AEs) (systemic and local)
timeFrame: Baseline and 4 weeks
measure: Change from baseline in Atopic Dermatitis (AD) score
timeFrame: Baseline and 4 weeks
measure: Change in pruritus
timeFrame: Baseline and 4 weeks
measure: Proportion of patients with change in Investigator Global Assessment (IGA)
timeFrame: Baseline and 3 weeks
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: Baseline and 4 weeks
Other outcomes:
measure: EASI improvement
timeFrame: Baseline and 4 weeks
measure: Change from baseline in body surface area (BSA).
timeFrame: Baseline and 4 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI).
timeFrame: Baseline and 4 weeks
measure: Change from baseline in Patient-Oriented Eczema Measure (POEM).
timeFrame: Baseline and 4 weeks
Locations:
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Burlington
country: Canada
facility: Manna Research Inc. (Burlington North)
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research inc.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Inc. (Toronto)
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research imc.
state: Ontation
city: Chicoutimi
country: Canada
facility: Q&T Research Chicoutimi
state: Quebec
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme Inc.
state: Quebec
city: Montréal
country: Canada
facility: Dr. David Gratton Dermatologue Inc.
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Study officials:
affiliation: Centre de Recherche Dernatologique du Quebec
name: Yves Poulin, MD
role: STUDY_DIRECTOR
affiliation: DermEffects
name: Wei Jing Loo, MD
role: STUDY_DIRECTOR
References: