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

Phase 2

Completed

• Conditions: Atopic Dermatitis Eczema
• Interventions: 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%

• Registration Number: NCT03540043
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2017-10-23
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-30
• Primary Completion: 2019-12-31
• Status Verified: 2020-06
• Study Completion: 2020-06-03
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Administration of Placebo	Administration of Placebo
PUR0110 (Thykamine) 0.05%	Administration of PUR0110 (Thykamine) 0.05%	Administration of PUR0110 (Thykamine) 0.05%
PUR0110 (Thykamine) 0.10%	Administration of PUR0110 (Thykamine) 0.1%	Administration of PUR0110 (Thykamine) 0.10%
PUR0110 (Thykamine) 0.25%	Administration of PUR0110 (Thykamine) 0.25%	Administration of PUR0110 (Thykamine) 0.25%

Primary Outcome Measures

Name	Time	Method
Efficacy as per investigator global assessment (IGA)	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

Name	Time	Method
Incidence and severity of adverse events (AEs) (systemic and local)	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.
Change in pruritus	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
Change from baseline in Atopic Dermatitis (AD) score	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
Proportion of patients with change in Investigator Global Assessment (IGA)	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
Change in Eczema Area and Severity Index (EASI)	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.

Trial Locations

Locations (12)

Dr. David Gratton Dermatologue Inc.; 🇨🇦 Montréal, Quebec, Canada

Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ); 🇨🇦 Québec, Canada

Windsor Clinical Research Inc.; 🇨🇦 Windsor, Ontario, Canada

Lynderm Research inc.; 🇨🇦 Markham, Ontario, Canada

Manna Research Inc. (Burlington North); 🇨🇦 Burlington, Ontario, Canada

DermEffects; 🇨🇦 London, Ontario, Canada

Manna Research Inc. (Toronto); 🇨🇦 Toronto, Ontario, Canada

Dr. Isabelle Delorme Inc.; 🇨🇦 Drummondville, Quebec, Canada

Centre de Recherche Saint-Louis; 🇨🇦 Québec, Quebec, Canada

Q&T Research Chicoutimi; 🇨🇦 Chicoutimi, Quebec, Canada

SimcoDerm Medical and Surgical Dermatology Center; 🇨🇦 Barrie, Ontario, Canada

DermEdge Research imc.; 🇨🇦 Mississauga, Ontation, Canada