Status:
COMPLETED
Phase I Study of GN-037 Cream for Psoriasis
Lead Sponsor:
TC Erciyes University
Collaborating Sponsors:
Monitor CRO
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be admi...
Detailed Description
In this single-center, randomized, double-blind, placebo-controlled, and two-stage Phase I study, it was planned to evaluate the safety, tolerability and clinical efficacy of topically applied GN-037 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Healthy Volunteers
- Male and female healthy volunteers aged 18-65 years\*
- Volunteers who were informed about participation in the study and agreed to give their written informed consent.
- Volunteers with negative qPCR SARS-CoV-2 result in nasopharyngeal or sputum samples
- Volunteers in good general health (without any known disease in the history and physical examination in the 14 days before participating in the study)
- Volunteers with negative HIV, Hepatitis B and C tests
- Volunteers with negative alcohol breath test
- Volunteers with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)
- Volunteers who agreed not to be exposed to the direct sun light during the study
- Female volunteers of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study
- Volunteers who can comply with all scheduled visits, laboratory tests and other study procedures \* The principal investigator will take the necessary measures to ensure that the representation
- Exclusion Criteria Healthy Volunteers
- Subjects with known hypersensitivity to any component of the study drug
- Female volunteers who are pregnant or breastfeeding or have a positive pregnancy test
- Volunteers with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit
- Patients with skin atrophy, pigmentation or extensive scarring that would preclude study evaluation at targeted treatment sites
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites
- Volunteers using moisturizing or skin softening ointment/lotion/cream on their intended treatment site within 3 days prior to enrollment in the study.
- Volunteers who cannot come to the study center for follow-up visits
- Volunteers taking part in another clinical study concurrently
- Volunteers with positive urine addictive drug screening test and/or alcohol test
- Inclusion Criteria For psoriatic patients
- Male and female patients aged 18-65 years\*
- Patients who were informed about participation in the study and agreed to give their written informed consent.
- Patients with negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples
- Patients diagnosed with plaque psoriasis by a dermatologist at least 6 months before inclusion in the study
- Patients whose lesions are less than 5% of the body surface area (BSA)
- Patients who did not receive local or systemic treatment for plaque psoriasis, or who received the last psoriasis treatment 28 days or more before
- Patients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that could affect the study evaluation.
- Patients with disease severity with Physician's Global Assessment (IGA) score ≥3 (moderate) as an overall assessment of all lesions to be treated
- Patients with negative HIV, Hepatitis B and C tests
- Patients with negative alcohol breath test
- Patients with negative urine addictive drug screening test (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)
- Patients who agreed not to be exposed to the sun during the study
- Female patients of childbearing potential must have a negative pregnancy test at the screening visit and must agree to use an effective method of contraception throughout the study
- Patients who can comply with all scheduled visits, laboratory tests, and other study procedures \* The principal investigator will take the necessary measures to ensure that the representation of females and males is equal.
- Exclusion criteria For psoriatic patients
- Patients with known hypersensitivity to any component of the study drug
- Pregnant or lactating or female patients with a positive pregnancy test
- Patients who require any other medication (topical or systemic) that may affect the course of the disease during the study period (eg antibiotics, antihistamines)
- Patients with a history of chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the screening visit
- Patients with skin atrophy, pigmentation, or extensive scarring that would preclude evaluation of study drug efficacy at targeted treatment sites
- Patients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the investigator's opinion, may affect study evaluations at targeted treatment sites
- Patients diagnosed with pustular, guttate, inverse, exfoliative or erythrodermic psoriasis at targeted treatment sites
- Patients with a history of psoriasis unresponsive to topical treatments
- Patients who used moisturizer or skin softening ointment/lotion/cream to the intended treatment areas within 3 days prior to enrolling in the study.
- Patients who cannot come to the study center for follow-up visits
- Patients taking part in another clinical study concurrently
- Patients with positive urine addictive drug screening test and/or alcohol test
Exclusion
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05428202
Start Date
March 28 2022
End Date
September 30 2022
Last Update
June 13 2023
Active Locations (1)
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1
Erciyes University IKUM Center
Kayseri, Turkey (Türkiye), 38110