Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05078567 |
| Other study ID # |
NLACCLAS02 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2021 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Microbio Co Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
I. Study Purpose
- Hypothesis: Natural lactic acid-enriched cream improves the Psoriasis Area and Severity
Index scores in plaque psoriasis patients.
- Primary Objective: To assess the clinical efficacy of natural lactic acid-enriched cream
for the proportion 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 in patients with
plaque psoriasis.
- Secondary Objectives:
1. To assess the safety of 12 week-treatment of natural lactic acid-enriched cream
application, as determined by the count of serious and non-serious
treatment-emergent adverse events (AEs) during the study period.
2. To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects
with plaque psoriasis.
3. To assess the TEWL, transepidermal water loss of natural lactic acid-enriched
cream.
II. Study Design and Methodology
- Subject This is an open-labeled exploratory study to evaluate safety and efficacy of
natural lactic acid-enriched cream in adults with plaque psoriasis. The study was
conducted at one medical center in Taiwan.
- 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.
- Investigational Product (IP) Natural lactic acid enriched cream: The natural lactic acid
enriched cream was produced by Microbio Co. Ltd. and contained active ingredient 5% lactic
acid is listed at 7 CFR Part 205.605 (a) as an approved nonsynthetic material produced by
microbial fermentation.
- Inclusion Criteria:
1. 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.
2. Capable of giving written informed consent 3. BSA involvement ≥ 5% and ≤ 10% 4. A PGA
score of 3 (moderate) at screening and baseline 5. 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.
6. 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
- Exclusion Criteria:
1. Psoriasis other than plaque variant 2. 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 4. 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 5. 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
- 2 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 6. Pregnant females or lactating females 7. Subjects have an allergic
history of soybean and soybean derivatives. 8. 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
- Primary Endpoint:
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
- Secondary Endpoints:
1. Number of subjects with ≥ 75% improvement in Psoriasis Area and Severity Index (PASI)
from Baseline at Week 4, 8 and 12.
2. Number of subjects with a PGA score of 0 or 1 at Week 4, 8, and 12.
3. Mean change in percent of total body surface area (%BSA) affected from Baseline to at
Week 4, 8 and 12.
4. Number of subjects with ≥90% improvement in PASI score from Baseline to Week 4, 8 and
12.
5. Mean Change in PASI Score From Baseline to Week 4, 8 and 12.
6. Mean Change in PGA Score From Baseline to Week 4, 8 and 12.
7. The mean percentage change from baseline in trans epidermal water loss (TEWL) to Week 4,
8 and 12.
- Safety Endpoint: The incidence of adverse events.
- Experimental Groups: single arm, natural lactic acid enriched cream 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
McNemar's test when comparing results in the same patient. The Fisher's 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 0.05.
For categorical variables, the Chi square test will be used. When any counting of the
expected frequency is less than 5, the Fisher's exact test will be conducted.
Significant alpha level will be adopted at 0.05
- 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.
