NCT02078297

Brief Summary

The goal of this project is to study some mechanisms involved in the dysregulation of the immune system observed in the skin of subjects with psoriasis. This will be done by analyzing specific immune cells as well as gene and protein expression in small skin samples (biopsies) from patients with psoriasis. These results will be compared to the skin of healthy subjects without psoriasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 28, 2014

Last Update Submit

March 25, 2015

Conditions

Scalp PsoriasisPustular Palmo-plantar PsoriasisNon-pustular Palmo-plantar PsoriasisElbow PsoriasisLower Leg Psoriasis

Keywords

IL-23IL-17ASkin biopsies

Outcome Measures

Primary Outcomes (1)

  • Source of IL 17A

    Explore the cellular source of IL 17A and mechanisms involved in the higher IL 17A/IL 23 expression ratio observed in palmo plantar skin of subjects with psoriasis

    Day 0

Secondary Outcomes (14)

  • Mechanism involved in the IL 17A/IL 23 expression ratio

    Day 0

  • Compare IL 17A expression in plaques from scalp against plaques from trunk or lower limbs

    Day 0

  • Compare IL 23 expression in plaques from scalp against plaques from trunk or lower limbs

    Day 0

  • Compare IL 17A expression in plaques from palms against plaques from trunk or lower limbs

    Day 0

  • Compare IL 23 expression in plaques from palms against plaques from trunk or lower limbs

    Day 0

  • +9 more secondary outcomes

Study Arms (6)

Scalp psoriasis

Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis.

pustular palmo-plantar psoriasis

Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis.

non-pustular palmo-plantar psoriasis

Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis.

elbow psoriasis

Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis.

leg psoriasis

Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis.

Healthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Invitation to volunteer

You may qualify if:

  • Subject, male or female, is aged 18 years or older at the screening visit.
  • Subject has a history of psoriasis for at least 6 months (does not apply to healthy volunteers).
  • Subject has psoriasis on the trunk and/or upper limbs and/or thighs in an area suitable for a skin biopsy (does not apply to healthy volunteers).
  • Subject has palmo-plantar pustular psoriasis or palmo-plantar non-pustular psoriasis or psoriasis on the scalp or elbows or lower limbs that is suitable for two skin biopsies (does not apply to healthy volunteers).
  • Female subject is willing to use effective contraceptive method for at least 30 days before Day 0 and at least until Day 10. Effective contraceptive methods are:
  • 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;
  • Intrauterine device (IUD);
  • Sterilization such as tubal ligation, hysterectomy or vasectomy;
  • Postmenopausal state for at least 1 year
  • Same-sex partner;
  • Abstinence.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening visit.
  • Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

You may not qualify if:

  • Female subject is pregnant or lactating.
  • Subject has used any topical treatment for psoriasis (except non medicated emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid, or zinc pyrithione.
  • Subject has used Ultra-Violet (UV) B phototherapy or excessive sun exposure less than 14 days before Day 0.
  • Subject has used any non biological systemic therapy for the treatment of psoriasis (including Psoralen Ultra-Violet A (PUVA) therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non biologics agents must be discontinued at least 28 days or 5 half lives prior to Day 0 (whichever is longer).
  • Subject is currently participating in a clinical trial with an experimental drug or device.
  • Subject who has used any biological therapy for the treatment of psoriasis less than 90 days before Day 0.
  • Subject is taking or requires oral or injectable corticosteroids. Inhaled corticosteroids for stable medical conditions are allowed. Subjects who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.
  • Subject is known to have hepatitis B or hepatitis C viral infection.
  • Subject is known to have immune deficiency or is immunocompromised or currently uses or plans to use anti retroviral therapy at any time during the study.
  • Subject is taking anti-coagulant medication (v.g. heparin, LMW (low molecular weight)-heparin, warfarin, anti-platelets (NSAID and aspirin will not be considered anti-platelets)) or has a contra indication to skin biopsies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies and blood samples will be taken. Samples will be retained until final analyses have been performed according to protocol and destroyed thereafter.

Study Officials

  • Robert Bissonnette, MD

    Innovaderm Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 5, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

CA(1)