Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05092464
Status:
UNKNOWN
Last Update Posted:
2021-10-25
First Post:
2021-10-13
Brief Title:
Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Atopic Dermatitis
Sponsor:
Microbio Co Ltd
Organization:
Microbio Co Ltd
Study Overview
Official Title:
An Open-Labeled Exploratory Study to Evaluate the Application of Natural Lactic Acid-enriched Cream in Adults With Atopic Dermatitis
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
I Study Purpose
Hypothesis
Natural lactic acid-enriched cream improves the Eczema Area and Severity Index scores in AD patients through inhibiting S aureus colonization
- Primary Objective The primary objective of this study is to assess the clinical efficacy of natural lactic acid-enriched cream for the improvement of Eczema Area and Severity Index EASI score in patients with atopic dermatitis
Secondary Objectives
1 To assess the safety of 12 week-treatment of natural lactic acid-enriched cream as determined by the count of serious and non-serious treatment-emergent adverse events AEs during the time period of every week per participant within each group
2 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Eczema Area and Severity Index EASI
3 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by SCORing Atopic Dermatitis SCORAD
4 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Validated Investigator Global Assessment for Atopic Dermatitis vIGA-AD
5 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Pruritus Numerical Rating Scale NRS
6 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Trans-epidermal Water Loss TWEL
Exploratory Objectives
1 To identify the diversity of the skin microbiome by DNA sequencing at day1 baseline visit weeks 4 12 and 16 of natural lactic acid-enriched cream
2 To compare the effect of 12 weeks of natural lactic acid-enriched cream treatment on S aureus abundance for up to 4 weeks after completion of treatment
3 To compare the change of S aureus abundance at day1 baseline visit weeks 4 12 and 16 of natural lactic acid-enriched cream application
II Study Design and Methodology
1 Subject This is a one-arm exploratory trial to evaluate the efficacy and safety of topical application of natural lactic acid-enriched cream on atopic dermatitis Patients with atopic dermatitis in the ages of 12 to 65 years with body surface area between 10 and 20 and an Investigators Global Assessment score of 3 moderate at baseline will be enrolled in this study
Sample size
Approximately 10 subjects who meet the criteria for study enrollment will be treated with natural lactic acid-enriched cream
- Treatment duration 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
The study includes 3 periods screening up to 4 weeks treatment 12 weeks and post-treatment follow-up 4 weeks Study visits occur at screening at weeks 1 2 4 8 and 12 and 2 and 4 weeks after the completion of treatment weeks 14 and 16 The study will be conducted in the Department of Dermatology Taipei Medical School-Shuang Ho Hospital Ministry of Health and Welfare
Inclusion Criteria
1 The subject is male or female between 12 and 65 years of age 2 The subject has a physician-confirmed diagnosis of chronic atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation
3 Body surface area BSA involvement between 10 and 20 excluding scalp at baseline
4 An IGA of atopic dermatitis score of 3 at baseline 5 At least one target lesion that measure at least 3 centimeter cm x 3 cm in size at Screening and Baseline and must be representative of the subjects disease state but not located on the hands feet or genitalia
Exclusion Criteria
1 Unstable course of atopic dermatitis spontaneously improving or rapidly deteriorating as determined by the investigator over the previous 4 weeks prior to Baseline
2 Used any of the following treatments within the indicated washout period before the baseline visit 12 weeks or 5 half-lives whichever is longer - biologic agents eg 18 weeks for omalizumab 8 weeks - cyclosporin methotrexate azathioprine or other systemic immunosuppressive or immunomodulating agents eg mycophenolate or tacrolimus 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs 1 weeks - topical treatments corticosteroids calcineurin inhibitors or coal tar on the body 2 weeks - sedating antihistamines non sedating antihistamines are permitted 1 week - topical antibiotics antibacterial cleansing body washsoap or diluted sodium hypochlorite bleach baths
3 Ultraviolet UV light therapy or prolonged exposure to natural or artificial sources of UV radiation eg sunlight or tanning booth within 4 weeks prior to the baseline visit andor intention to have such exposure during the study which is thought by the investigator to potentially impact the subjects atopic dermatitis
4 The subject planned or anticipated use of any prohibited medications and procedures during study treatment
5 Active bacterial viral or fungal skin infections
6 Participants with any systemic disorder active skin disease or subjects who present with scars moles tattoos sunburn in the test area which could interfere with the assessment of lesions at screening
7 Participant who is immunocompromised eg history of lymphoma Human Immunodeficiency Virus HIV Acquired Immune Deficiency Syndrome AIDS Wiskott-Aldrich Syndrome or has a history of malignant disease with the exception of non- melanoma skin cancer
8 Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
9 Subjects have an allergic history of soybean and soybean-derivatives
10 Pregnant or lactating females or females who desire to become pregnant andor breast feed within the duration of study participation
11 The subject planned or anticipated major surgical procedure during the patients participation in this study
Primary Endpoint
The mean change from baseline in EASI at week 12
Secondary Endpoints
1 The occurrence of at least one serious or non-serious treatment-emergent AE during the time period of day1 to week 12
2 Proportion of patients with EASI 75 75 improvement from baseline at weeks 1 2 4 8 12 14 and 16
3 The mean percentage change from baseline in EASI score at weeks 1 2 4 8 12 14 and 16
4 Proportion of patients with both vIGA-AD 0 to 1and a reduction from baseline of 2 points at weeks 1 2 4 8 12 14 and 16
5 The mean percentage change from baseline in vIGA-AD score at weeks 1 2 4 8 12 14 and 16
6 The mean percentage change from baseline in SCORAD score at weeks 1 2 4 8 12 14 and 16
7 The mean percentage change from baseline in NRS score at weeks 1 2 4 8 12 14 and 16
8 The mean percenage change from baseline in transepidermal water loss TEWLat weeks 1 2 4 8 12 14 and 16
Safety Endpoint
1 The incidence of adverse events
2 Experimental Groups single-arm natural lactic acid-enriched cream
3 Clinical sample collection To explore the diversity of the skin microbiome skin microbiota will be harvested by swapping method at day 1 baseline visit weeks 4 12 and 16 DNA sequencing will be applied to clarify the composition of cutaneous microbiota at indicated time points
III Statistical Analysis
General Statistics
For continuous variables the following will be presented mean median standard deviation minimum and maximum The comparison between two treatment groups and the comparison within group will be tested by using two independent t-test and paired t-test respectively If the normal assumption is violated the Wilcoxon rank-sum and Wilcoxon signed-rank test will be conducted respectively
For categorical variables the numbers and percentages of subjects will be listed and summarized Comparison for percentages will be performed using the Chi-square test and McNemars test when comparing results in the same patient The Fishers exact test will replace the Chi-square test when any counting of the expected frequency is less than 5
- Endpoints To perform the primary efficacy and other endpoints for continuous variable two independent t-test will be used If the normal assumption is violated the non-parametric method of Wilcoxon rank-sum test will be applied for analysis Significant level will be adopted with two-side at 005
For categorical variables the Chi-square test will be used When any counting of the expected frequency is less than 5 the Fishers exact test will be conducted Significant alpha level will be adopted at 005
- Safety Adverse events will be coded by preferred term PT and system organ class SOC by the latest version of MedDRA Adverse events will be summarized by severity relationship to study drug SAEs and AEs leading to discontinuation of study drug
Physical examination findings will be presented in a tabulated listing
Hypothesis
Natural lactic acid-enriched cream improves the Eczema Area and Severity Index scores in AD patients through inhibiting S aureus colonization
- Primary Objective The primary objective of this study is to assess the clinical efficacy of natural lactic acid-enriched cream for the improvement of Eczema Area and Severity Index EASI score in patients with atopic dermatitis
Secondary Objectives
1 To assess the safety of 12 week-treatment of natural lactic acid-enriched cream as determined by the count of serious and non-serious treatment-emergent adverse events AEs during the time period of every week per participant within each group
2 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Eczema Area and Severity Index EASI
3 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by SCORing Atopic Dermatitis SCORAD
4 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Validated Investigator Global Assessment for Atopic Dermatitis vIGA-AD
5 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Pruritus Numerical Rating Scale NRS
6 To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with atopic dermatitis by Trans-epidermal Water Loss TWEL
Exploratory Objectives
1 To identify the diversity of the skin microbiome by DNA sequencing at day1 baseline visit weeks 4 12 and 16 of natural lactic acid-enriched cream
2 To compare the effect of 12 weeks of natural lactic acid-enriched cream treatment on S aureus abundance for up to 4 weeks after completion of treatment
3 To compare the change of S aureus abundance at day1 baseline visit weeks 4 12 and 16 of natural lactic acid-enriched cream application
II Study Design and Methodology
1 Subject This is a one-arm exploratory trial to evaluate the efficacy and safety of topical application of natural lactic acid-enriched cream on atopic dermatitis Patients with atopic dermatitis in the ages of 12 to 65 years with body surface area between 10 and 20 and an Investigators Global Assessment score of 3 moderate at baseline will be enrolled in this study
Sample size
Approximately 10 subjects who meet the criteria for study enrollment will be treated with natural lactic acid-enriched cream
- Treatment duration 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
The study includes 3 periods screening up to 4 weeks treatment 12 weeks and post-treatment follow-up 4 weeks Study visits occur at screening at weeks 1 2 4 8 and 12 and 2 and 4 weeks after the completion of treatment weeks 14 and 16 The study will be conducted in the Department of Dermatology Taipei Medical School-Shuang Ho Hospital Ministry of Health and Welfare
Inclusion Criteria
1 The subject is male or female between 12 and 65 years of age 2 The subject has a physician-confirmed diagnosis of chronic atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation
3 Body surface area BSA involvement between 10 and 20 excluding scalp at baseline
4 An IGA of atopic dermatitis score of 3 at baseline 5 At least one target lesion that measure at least 3 centimeter cm x 3 cm in size at Screening and Baseline and must be representative of the subjects disease state but not located on the hands feet or genitalia
Exclusion Criteria
1 Unstable course of atopic dermatitis spontaneously improving or rapidly deteriorating as determined by the investigator over the previous 4 weeks prior to Baseline
2 Used any of the following treatments within the indicated washout period before the baseline visit 12 weeks or 5 half-lives whichever is longer - biologic agents eg 18 weeks for omalizumab 8 weeks - cyclosporin methotrexate azathioprine or other systemic immunosuppressive or immunomodulating agents eg mycophenolate or tacrolimus 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs 1 weeks - topical treatments corticosteroids calcineurin inhibitors or coal tar on the body 2 weeks - sedating antihistamines non sedating antihistamines are permitted 1 week - topical antibiotics antibacterial cleansing body washsoap or diluted sodium hypochlorite bleach baths
3 Ultraviolet UV light therapy or prolonged exposure to natural or artificial sources of UV radiation eg sunlight or tanning booth within 4 weeks prior to the baseline visit andor intention to have such exposure during the study which is thought by the investigator to potentially impact the subjects atopic dermatitis
4 The subject planned or anticipated use of any prohibited medications and procedures during study treatment
5 Active bacterial viral or fungal skin infections
6 Participants with any systemic disorder active skin disease or subjects who present with scars moles tattoos sunburn in the test area which could interfere with the assessment of lesions at screening
7 Participant who is immunocompromised eg history of lymphoma Human Immunodeficiency Virus HIV Acquired Immune Deficiency Syndrome AIDS Wiskott-Aldrich Syndrome or has a history of malignant disease with the exception of non- melanoma skin cancer
8 Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
9 Subjects have an allergic history of soybean and soybean-derivatives
10 Pregnant or lactating females or females who desire to become pregnant andor breast feed within the duration of study participation
11 The subject planned or anticipated major surgical procedure during the patients participation in this study
Primary Endpoint
The mean change from baseline in EASI at week 12
Secondary Endpoints
1 The occurrence of at least one serious or non-serious treatment-emergent AE during the time period of day1 to week 12
2 Proportion of patients with EASI 75 75 improvement from baseline at weeks 1 2 4 8 12 14 and 16
3 The mean percentage change from baseline in EASI score at weeks 1 2 4 8 12 14 and 16
4 Proportion of patients with both vIGA-AD 0 to 1and a reduction from baseline of 2 points at weeks 1 2 4 8 12 14 and 16
5 The mean percentage change from baseline in vIGA-AD score at weeks 1 2 4 8 12 14 and 16
6 The mean percentage change from baseline in SCORAD score at weeks 1 2 4 8 12 14 and 16
7 The mean percentage change from baseline in NRS score at weeks 1 2 4 8 12 14 and 16
8 The mean percenage change from baseline in transepidermal water loss TEWLat weeks 1 2 4 8 12 14 and 16
Safety Endpoint
1 The incidence of adverse events
2 Experimental Groups single-arm natural lactic acid-enriched cream
3 Clinical sample collection To explore the diversity of the skin microbiome skin microbiota will be harvested by swapping method at day 1 baseline visit weeks 4 12 and 16 DNA sequencing will be applied to clarify the composition of cutaneous microbiota at indicated time points
III Statistical Analysis
General Statistics
For continuous variables the following will be presented mean median standard deviation minimum and maximum The comparison between two treatment groups and the comparison within group will be tested by using two independent t-test and paired t-test respectively If the normal assumption is violated the Wilcoxon rank-sum and Wilcoxon signed-rank test will be conducted respectively
For categorical variables the numbers and percentages of subjects will be listed and summarized Comparison for percentages will be performed using the Chi-square test and McNemars test when comparing results in the same patient The Fishers exact test will replace the Chi-square test when any counting of the expected frequency is less than 5
- Endpoints To perform the primary efficacy and other endpoints for continuous variable two independent t-test will be used If the normal assumption is violated the non-parametric method of Wilcoxon rank-sum test will be applied for analysis Significant level will be adopted with two-side at 005
For categorical variables the Chi-square test will be used When any counting of the expected frequency is less than 5 the Fishers exact test will be conducted Significant alpha level will be adopted at 005
- Safety Adverse events will be coded by preferred term PT and system organ class SOC by the latest version of MedDRA Adverse events will be summarized by severity relationship to study drug SAEs and AEs leading to discontinuation of study drug
Physical examination findings will be presented in a tabulated listing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None