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

NCT03540043 | Completed Phase 2

• 1 other identifier: DV16-PUR0110-C001
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 12

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

Conditions

Atopic Dermatitis Eczema

Keywords

Mild moderate atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Efficacy as per investigator global assessment (IGA)

  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.

  Baseline and 4 weeks

Secondary Outcomes (5)

• Incidence and severity of adverse events (AEs) (systemic and local)

  Baseline and 4 weeks

• Change from baseline in Atopic Dermatitis (AD) score

  Baseline and 4 weeks

• Change in pruritus

  Baseline and 4 weeks

• Proportion of patients with change in Investigator Global Assessment (IGA)

  Baseline and 3 weeks

• Change in Eczema Area and Severity Index (EASI)

  Baseline and 4 weeks

Other Outcomes (4)

• EASI improvement

  Baseline and 4 weeks

• Change from baseline in body surface area (BSA).

  Baseline and 4 weeks

• Change from baseline in Dermatology Life Quality Index (DLQI).

  Baseline and 4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Administration of Placebo

Drug: Administration of Placebo

PUR0110 (Thykamine) 0.05%

EXPERIMENTAL

Administration of PUR0110 (Thykamine) 0.05%

Drug: Administration of PUR0110 (Thykamine) 0.05%

PUR0110 (Thykamine) 0.10%

EXPERIMENTAL

Administration of PUR0110 (Thykamine) 0.10%

Drug: Administration of PUR0110 (Thykamine) 0.1%

PUR0110 (Thykamine) 0.25%

EXPERIMENTAL

Administration of PUR0110 (Thykamine) 0.25%

Drug: Administration of PUR0110 (Thykamine) 0.25%

Interventions

Administration of Placebo DRUG

Botanical Drug Phase 2 clinical study

Also known as: Placebo control

Placebo

Administration of PUR0110 (Thykamine) 0.05% DRUG

Botanical Drug Phase 2 clinical study

Also known as: Active arm

PUR0110 (Thykamine) 0.05%

Administration of PUR0110 (Thykamine) 0.1% DRUG

Botanical Drug Phase 2 clinical study

Also known as: Active arm

PUR0110 (Thykamine) 0.10%

Administration of PUR0110 (Thykamine) 0.25% DRUG

Botanical Drug Phase 2 clinical study

Also known as: Active arm

PUR0110 (Thykamine) 0.25%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must meet all the following criteria to be enrolled in the study:
• Male or female patients, aged 18 years or older at the screening visit.
• 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).
• Patients with BSA ≥ 1 % and ≤ 15% at Day 0 (excluding palms, soles and scalp).
• Patients with IGA score of 2 to 3 (mild-to-moderate) at Day 0.
• 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.
• 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).
• Patients must be capable of giving informed consent and the consent must be obtained prior to any study related procedures.

You may not qualify if:

• Patient with BSA \> 15% (excluding palms, soles and scalp).
• Female who is pregnant or lactating or wishes to become pregnant during the study period.
• 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.
• Patient with spontaneously improving or rapidly deteriorating AD.
• Patient with active allergic contact dermatitis or other non-atopic forms of dermatitis.
• Patient with active cutaneous bacterial or viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
• Patient with acute infections.
• 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.
• Patient with bleeding disorders.
• Patient with known seropositivity for the human immunodeficiency virus or evidence of active hepatitis B or C.
• 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.
• Patient has a history of alcoholism or drug abuse within 12 months prior to Day 0.
• 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.
• Patient with a history of severe food allergies.
• Patient with sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline (Day 0), which would interfere with evaluations.

Sponsors & Collaborators

• PurGenesis Technologies Inc.: lead

Study Sites (12)

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Manna Research Inc. (Burlington North)

Burlington, Ontario, L7M 4Y1, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research inc.

Markham, Ontario, L3P 1X2, Canada

Location

Manna Research Inc. (Toronto)

Toronto, Ontario, M9W 4L6, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W5L7, Canada

Location

DermEdge Research imc.

Mississauga, Ontation, L5H 1G9, Canada

Location

Q&T Research Chicoutimi

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Dr. Isabelle Delorme Inc.

Drummondville, Quebec, J2B 5L4, Canada

Location

Dr. David Gratton Dermatologue Inc.

Montreal, Quebec, H3H 1V4, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

Québec, G1V 4X7, Canada

Location

Study Officials

• Yves Poulin, MD

  Centre de Recherche Dernatologique du Quebec

  STUDY DIRECTOR

• Wei Jing Loo, MD

  DermEffects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Parallel-Group, Placebo-controlled

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 30, 2018
• Study Start: October 23, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 3, 2020
• Last Updated: September 16, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)