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Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03540043
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
PurGenesis Technologies Inc.

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Administration of Placebo Drug: Administration of PUR0110 (Thykamine) 0.05% Drug: Administration of PUR0110 (Thykamine) 0.1% Drug: Administration of PUR0110 (Thykamine) 0.25% Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Parallel-Group, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: TReatment were packaged in identical jars. Eligible patients will be randomized in a 1:1:1:1 ratio to receive either one of 3 concentrations of PUR 0110 cream (0.05%, 0.1% and 0.25%) or vehicle (placebo).
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo
Administration of Placebo
Drug: Administration of Placebo
Botanical Drug Phase 2 clinical study
Other Name: Placebo control

Experimental: PUR0110 (Thykamine) 0.05%
Administration of PUR0110 (Thykamine) 0.05%
Drug: Administration of PUR0110 (Thykamine) 0.05%
Botanical Drug Phase 2 clinical study
Other Name: Active arm

Experimental: PUR0110 (Thykamine) 0.10%
Administration of PUR0110 (Thykamine) 0.10%
Drug: Administration of PUR0110 (Thykamine) 0.1%
Botanical Drug Phase 2 clinical study
Other Name: Active arm

Experimental: PUR0110 (Thykamine) 0.25%
Administration of PUR0110 (Thykamine) 0.25%
Drug: Administration of PUR0110 (Thykamine) 0.25%
Botanical Drug Phase 2 clinical study
Other Name: Active arm




Primary Outcome Measures :
  1. Efficacy as per investigator global assessment (IGA) [ Time Frame: Baseline and 4 weeks ]
    Efficacy as per investigator global assessment (IGA) of clear (0), almost clear (1) at Day 29 and with a decrease from baseline in IGA of at least 2 grades at Day 29.


Secondary Outcome Measures :
  1. Incidence and severity of adverse events (AEs) (systemic and local) [ Time Frame: Baseline and 4 weeks ]
    Incidence and severity of adverse events (AEs) (systemic and local) as a measure of safety and tolerability of treatment for up to Day 29.

  2. Change from baseline in Atopic Dermatitis (AD) score [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in the 4 individual signs/symptoms score of AD including: erythema, induration/papulation, excoriation and lichenification measured in the target lesion on a 4-point scale defined as : 0 = None; 1=Mild; 2=Moderate and 3=Severe

  3. Change in pruritus [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in pruritus, measured on a 4-point scale defined as : 0=None; 1=Mild; 2=Moderate and 3=Severe

  4. Proportion of patients with change in Investigator Global Assessment (IGA) [ Time Frame: Baseline and 3 weeks ]
    • Proportion of patients with an IGA of clear (0), almost clear (1) and with a decrease from baseline in IGA of at least 2 grades at intermediate visits (Days 7, 14 and 21). Scores being defined as : 0=Clear ; 1=Almost Clear; 2:=Mild disease; 3=Moderate disease and 4 = Severe disease

  5. Change in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in Eczema Area and Severity Index (EASI).Four body regions are considered separately and include: Head and neck; Trunk ; Upper extremities; Lower extremities (including the buttocks).Extent of Eczema in these regions is being scored as follow : 0 = 0% involvement; 1= 1-9%; 2 = 10-29%; 3= 30-49%; 4= 50-69%; 5= 70-89% and 6= 90-100%. Severity of erythema, edema/papulation, excoriation and lichenification , for each region is scaled as : 0=none; 1= mild; 2= moderate and 3= severe. Final EASI score is the sum of the 4 region scores and ranges from 0-72.


Other Outcome Measures:
  1. EASI improvement [ Time Frame: Baseline and 4 weeks ]
    Proportion of patients with at least a 50% and 75% improvement in EASI (EASI50) at Day 29 as compared to baseline

  2. Change from baseline in body surface area (BSA). [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in body surface area (BSA) affected by disease.

  3. Change from baseline in Dermatology Life Quality Index (DLQI). [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in Dermatology Life Quality Index (DLQI) evaluating the impact on Quality of life scale : Very much ; A lot; a little or Not at all.

  4. Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 4 weeks ]
    Change from baseline to Day 29 in Patient-Oriented Eczema Measure (POEM) investigating the number of days patients have been subjected, due to eczema, to itchy skin, sleep disturbance; skin bleeding; skin weeping; skin craked; skin flaking and skin dryness. Scale defined as : 0 = no days; 1= 1-2 days; 2= 3-4 days; 3= 5-6 days; 4 = everyday



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540043


Contacts
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Contact: ANDRE BOULET, PhD 5142487509 apboulet@groupedevonian.com

Locations
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Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
Contact: Maryam Alam, MD    705-503-6331      
DermEffects Recruiting
London, Ontario, Canada, N6H 5L5
Contact: Wei Jing Loo, MD    519-472-2929      
Lynderm Research inc. Recruiting
Markham, Ontario, Canada, L3P 1X2
Contact: Charles Lynde, MD    905-471-8011      
Canada, Ontation
DermEdge Research imc. Recruiting
Mississauga, Ontation, Canada, L5H 1G9
Contact: Mark Lomaga, MD    905-274-9996      
Canada, Quebec
Dr. David Gratton Dermatologue Inc. Recruiting
Montréal, Quebec, Canada, H3H 1V4
Contact: David Gratton, MD    514-933-0020      
Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) Recruiting
Québec, Canada, G1V 4X7
Contact: Yves Poulin, MD    418-650-0777      
Sponsors and Collaborators
PurGenesis Technologies Inc.
Investigators
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Study Director: Yves Pouln, MD Centre de Recherche Dernatologique du Quebec
Study Director: Wei Jing Loo, MD DermEffects

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Responsible Party: PurGenesis Technologies Inc.
ClinicalTrials.gov Identifier: NCT03540043     History of Changes
Other Study ID Numbers: DV16-PUR0110-C001
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by PurGenesis Technologies Inc.:
Mild moderate atopic dermatitis

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases