AzTrials
AzTrials

Atopic Dermatitis EczemaPhase 2NCT03540043

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

A Phase 2 study testing Administration of PUR0110 (Thykamine) 0.05%, Administration of PUR0110 (Thykamine) 0.1% and Administration of PUR0110 (Thykamine) 0.25% in people with Atopic Dermatitis Eczema, run by PurGenesis Technologies Inc. at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis Eczema
What is being tested?
Administration of PUR0110 (Thykamine) 0.05%, Administration of PUR0110 (Thykamine) 0.1% and Administration of PUR0110 (Thykamine) 0.25%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
12 sitesCanada
Study dates
23 Oct 2017to 3 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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).
Show all 22Show fewer
  • 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.
  • 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.
  • Use within 2 weeks of baseline (Day 0) of systemic antibiotics, calcipotriene or other vitamin D preparations, or retinoids.
  • Use within 2 weeks of baseline (Day 0) of oral natural health products or vitamins containing lutein.
  • 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.
  • 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).
  • Use of an investigational agent within 4 weeks or 5 half-lives prior to Day 0 (whichever is longer).
  • Patient not willing to minimize or avoid natural and artificial sunlight exposure during treatment.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

  • Manna Research Inc. (Burlington North)

    Burlington, Ontario, L7M 4Y1

  • Q&T Research Chicoutimi

    Chicoutimi, Quebec, G7H 7Y8

  • Dr. Isabelle Delorme Inc.

    Drummondville, Quebec, J2B 5L4

  • DermEffects

    London, Ontario, N6H 5L5

  • Lynderm Research inc.

    Markham, Ontario, L3P 1X2

  • DermEdge Research imc.

    Mississauga, Ontation, L5H 1G9

  • Dr. David Gratton Dermatologue Inc.

    Montreal, Quebec, H3H 1V4

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4

  • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

    Québec, G1V 4X7

  • Manna Research Inc. (Toronto)

    Toronto, Ontario, M9W 4L6

  • Windsor Clinical Research Inc.

    Windsor, Ontario, N8W5L7

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
Administration of Placebo, Administration of PUR0110 (Thykamine) 0.05%, Administration of PUR0110 (Thykamine) 0.1%, Administration of PUR0110 (Thykamine) 0.25%
Keywords
Mild moderate atopic dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of PlaceboDrug

    Also called Placebo control

    Botanical Drug Phase 2 clinical study

  • Administration of PUR0110 (Thykamine) 0.05%Drug

    Also called Active arm

    Botanical Drug Phase 2 clinical study

  • Administration of PUR0110 (Thykamine) 0.1%Drug

    Also called Active arm

    Botanical Drug Phase 2 clinical study

  • Administration of PUR0110 (Thykamine) 0.25%Drug

    Also called Active arm

    Botanical Drug Phase 2 clinical study

Study groups in NCT03540043
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAdministration of Placebo
Receives: Drug: Administration of Placebo
PUR0110 (Thykamine) 0.05%ExperimentalAdministration of PUR0110 (Thykamine) 0.05%
Receives: Drug: Administration of PUR0110 (Thykamine) 0.05%
PUR0110 (Thykamine) 0.10%ExperimentalAdministration of PUR0110 (Thykamine) 0.10%
Receives: Drug: Administration of PUR0110 (Thykamine) 0.1%
PUR0110 (Thykamine) 0.25%ExperimentalAdministration of PUR0110 (Thykamine) 0.25%
Receives: Drug: Administration of PUR0110 (Thykamine) 0.25%

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 4 weeks

Secondary outcomes (5)

  1. Incidence and severity of adverse events (AEs) (systemic and local)

    Incidence and severity of adverse events (AEs) (systemic and local) as a measure of safety and tolerability of treatment for up to Day 29.

    Measured: Baseline and 4 weeks

  2. Change from baseline in Atopic Dermatitis (AD) score

    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

    Measured: Baseline and 4 weeks

  3. Change in pruritus

    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

    Measured: Baseline and 4 weeks

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

    • 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

    Measured: Baseline and 3 weeks

  5. Change in Eczema Area and Severity Index (EASI)

    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.

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start23 Oct 2017
  3. Primary completion31 Dec 2019
  4. Study completion3 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Parallel-Group, Placebo-controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03540043
Sponsor's protocol ID
DV16-PUR0110-C001
Status last verified
Jun 2020
First submitted
15 Apr 2018
Last updated
16 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Administration of PUR0110 (Thykamine) 0.05%, Administration of PUR0110 (Thykamine) 0.1% and Administration of PUR0110 (Thykamine) 0.25% in people with Atopic Dermatitis Eczema, run by PurGenesis Technologies Inc. at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy as per investigator global assessment (IGA) (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03540043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in