Skip to content

Evaluation of the efficacy and safety of skin-microbiome-derived skin barrier-enhancing cosmetics in atopic dermatitis: a proof-of-concept trial

Evaluation of the efficacy and safety of skin-microbiome-derived skin barrier-enhancing cosmetics in atopic dermatitis: a proof-of-concept trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007876
Enrollment
100
Registered
2022-11-03
Start date
2022-11-02
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : This study was conducted based on 8-week application, randomization of test site, double-blind, and control comparison (vs. control), and the researcher met 90 study subjects who met the sele

Sponsors

Korean Skin Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male or female volunteers aged 12 to 70 years with a diagnosis of atopic dermatitis IGA = 2 or 3 at screening and prior to product use 2) Volunteers with mild to moderate atopic dermatitis IGA = 2 or 3 at screening and prior to product use 3) Volunteers who have applied a stable dose of moisturizer at least once daily for at least 7 consecutive days prior to study entry 4) Volunteers who have been fully informed about the study and have voluntarily completed and signed an informed consent form. 5) Volunteers who can be followed up for the duration of the study

Exclusion criteria

Exclusion criteria: 1) Treatment with immunosuppressive/immunomodulatory medications or phototherapy for atopic dermatitis within the last 4 weeks or volunteers who, in the opinion of the investigator, are likely to require such treatment(s) during the 4-week period. 2) Volunteers treated with topical corticosteroids or topical calcineurin inhibitors within the last 2 weeks 3) Volunteers who have been treated with a biologic agent (e.g., omalizumab, dupilumab, and infliximab) within the last 16 weeks 4) Volunteers who have started treatment for atopic dermatitis with a new moisturizer prescription during the screening period 5) Volunteers planning or using any prohibited treatment during the study period 6) Volunteers who have been treated with a live (attenuated) vaccine within the last 12 weeks 7) Volunteers requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within the last 2 weeks 8) Volunteers with an active chronic or acute infection 9) Volunteers with a serious skin infection or skin disease within the last 1 week that may interfere with the study evaluation 10) Volunteers with chronic urticaria or active pruritus due to allergens such as scabies or insect bites within the past 1 week 11) Applicants with a history of human immunodeficiency virus (HIV) infection or a positive HIV serologic test at screening 12) Applicants with a history of alcohol or drug abuse within 2 years 13) Applicants with acute or chronic hepatitis or known cirrhosis 14) Volunteers with a history of malignancy within 5 years 15) Volunteers with comorbid severe condition(s) as determined by the investigator 16) Volunteers with planned or anticipated significant surgery during this period 17) Volunteers who are employees or family members of the study 18) Female volunteers who are pregnant or lactating or who plan to become pregnant or lactate during the study

Design outcomes

Primary

MeasureTime frame
IGA (Investigator’s Global Assessment)

Secondary

MeasureTime frame
Measurement of pruritus visual analog scale (VAS) ;Measurement of skin hydration and transepidermal water loss (TEWL) ;EASI (Eczema area and severity index) score

Countries

Korea, Republic of

Contacts

Public ContactBo Bae Oh

Korean Skin Research Center

bboh@koreansrc.com+82-31-712-8520

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026