Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Plaque Psoriasis

NCT05078567 | Unknown

• 1 other identifier: NLACCLAS02
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Psoriasis is a chronic and immune mediated skin disorder that presents with plaques of thickened, scaly skin. Up to 71% patients suffer from psoriasis, leading to high impact on their daily life. Plaque psoriasis is the most common type which causes thick, scaly patches of skin. Although the treatment of moderate-to-severe psoriasis has been improved with the new launched biologics, topical therapies continue to play a key role in the management of mild-to-moderate psoriasis. Up to 80% of patients of psoriasis use topical agents as their first-line therapy, including topical vitamin D analogs, corticosteroids, vitamin A analogs, and anthralin. There are well-documented concerns and limitations with current topical treatments. In this study, we propose a nature lactic acid enriched cream with a high safety profile as an alternative choice for patients with plaque psoriasis. Lactic acid is a natural moisturizing factor, which exists in healthy skin. It can efficiently prevent water loss from the skin and alleviate allergic reactions caused by dry skin. The moisturized function of lactic acid has made it became a commonly used additive in a wide variety of skincare products, such as lotion, cream, butter and spray. This product is rich in natural lactic acid generated by the fermentation of probiotics, and therefore can relieve skin itching caused by skin dryness, and resume the water-holding capability of the skin by removing abnormally proliferative stratum corneum as well as inducing collagen production. Importantly, this product is a steroid-free product with safety and without any induced adverse effects in use. This product is also can be a promising option other than steroids to be applied for the mitigation of recurrent symptoms in plaque psoriasis by resuming the water-retention ability of skin and rebuilding skin barrier function.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Physician Global Assessment (PGA) score

  Numbers of subjects who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2 grade improvement from Baseline at Week 12

  Week 12

Study Arms (1)

Single arm open label study

EXPERIMENTAL

Topical used natural lactic acid-enriched cream twice daily.

Device: 5% Natural Lactic Acid-enriched Cream

Interventions

5% Natural Lactic Acid-enriched Cream DEVICE

The subjects were required to topically apply natural lactic acid-enriched cream twice daily in the morning and evening for the treatment duration of 12 weeks.

Single arm open label study

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ages 20 to 65 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
• Capable of giving written informed consent
• BSA involvement ≥ 5% and ≤ 10%
• A PGA score of 3 (moderate) at screening and baseline
• One target plaque located on the trunk or proximal parts of extremities (excluding knees, elbows, and intertriginous areas) that is at least 3 (centimeter) cm х 3 cm in size at Screening and Baseline with a severity representative of the subject's overall disease.
• Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment

You may not qualify if:

• Psoriasis other than plaque variant
• Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit; chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
• Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
• Use of any prohibited medication within the indicated period before the first dose of study drug:
• Within a minimum of 5 half lives for biologic agents
• Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
• weeks for immunizations with a live viral component
• Drugs known to possibly worsen psoriasis, unless on a stable dose for \> 12 weeks
• With the exception of non medicated emollients, 1 week for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar
• Any investigational product within 30 days, 5 half lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
• Pregnant females or lactating females
• Subjects have an allergic history of soybean and soybean derivatives.
• History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 14, 2021
• Study Start: October 31, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10