Phase I Study of GN-037 Cream for Psoriasis

NCT05428202 | Completed Phase 1

• 1 other identifier: MON839.151.5
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.

Conditions

Psoriasis

Keywords

Psoriasis; Phase 1 Study; Healthy Volunteers; Patients; Investigational Drug

Outcome Measures

Primary Outcomes (1)

• Severity of Adverse Events and Serious Adverse Events.

  Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

  28 days

Secondary Outcomes (4)

• Percent Change From Baseline in Total Plaque Severity Score in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application.

  19 days

• Percent Change From Baseline in Target Plaque Area in Psoriasis Patients From baseline at days 6 and 14 with GN-037 cream application. [ Time Frame: 19 days ]

  19 days

• Difference in Psoriasis Area Severity Index (PASI) From baseline at days 6 and 14 with GN-037 cream application.

  19 days

• Change in Physician Global Assessment (PGA) score From Baseline achieved at days 6 and 14 with GN-037 cream application.

  19 days

Study Arms (2)

GN 037 cream

EXPERIMENTAL

Healthy volunteers will receive GN037 cream in 2 to 1 ration Application will be done twice daily, to selected area of body on the fore arm: Increasing dosages of dosages: Low dose to a 5 cm2 skin area, Medium dose to15 cm2 skin area, High dose to 30 cm2 skin area Psoriatic patients will receive GN037 cream Aplication twice daily, to a selected body target lesion High dose 30 cm2

Drug: GN037

Placebo Cream

PLACEBO COMPARATOR

Placebo cream will be applied in 2 to 1 ratio twice daily, to selected area of fore arm. Low dose to 5 cm2 skin area, Medium dose 15 cm2 skin area, High dose 30 cm2 skin area

Drug: Placebo

Interventions

GN037 DRUG

GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo

Also known as: Active

GN 037 cream

Placebo DRUG

Placebo cream containing base without active ingredients

Also known as: Placebo Cream

Placebo Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 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.

Sponsors & Collaborators

• TC Erciyes University: lead
• Monitor CRO: collaborator

Study Sites (1)

Erciyes University IKUM Center

Kayseri, 38110, Turkey (Türkiye)

Location

Related Publications (1)

• Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10.

  PMID: 37300792 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Oğuz Akbaş, MD

  Monitor CRO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical tubes with no indicative label, identical creams with similiar texture and odor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 23, 2022
• Study Start: March 28, 2022
• Primary Completion: April 28, 2022
• Study Completion: September 30, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)