Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Atopic Dermatitis

NCT05092464 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-25

No results posted yet for this study

Summary

Atopic dermatitis (AD) is the most common chronic inflammatory skin disorder, with a lifetime prevalence of 15-25% in children and 1-3% in adults worldwide. AD is a heterogeneous disease induced by multiple factors, including genetic mutation and environmental risk factors. The main inflammatory mechanism that contributed to AD is the immune response mediated by T helper 2 (Th2) cells. The clinical features of AD, such as recurrent eczematous lesions, IgE-mediated intense itch, and the disruption of skin barrier induced by abnormal epidermal cell differentiation and protein structures, etc., can be attributed to the secretion of Th2 cell-related cytokines. AD is likely to be a lifelong illness with repeated onsets, causing not only physiological discomfort but also psychological distress; hence the quality of life of AD patients is inevitably affected.

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 atopic dermatitis by resuming the water-retention ability of skin and rebuilding skin barrier function.

Conditions

Interventions

DEVICE

Natural Lactic Acid-enriched Cream

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.

Sponsors & Collaborators

  • Microbio Co Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-03-31
Completion
2022-04-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092464 on ClinicalTrials.gov