| CTRI Number |
CTRI/2024/11/076652 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test products in mild to moderate Atopic Dermatitis (AD) patients. |
|
Scientific Title of Study
|
An Exploratory, Proof-of-Concept, Double-Blind, Placebo-Controlled, Randomized, Comparative, Interventional, Prospective, Safety In-Use Tolerability and Efficacy Study of Test Products in Patients with Mild to Moderate Atopic Dermatitis (AD). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240037-BM , 1.0, 14 Oct 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Merja Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub- Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, KhoraJ
Gandhinagar
GUJARAT
382421
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Blossom Microbiotics LLC, 4111-E Rose Lake Dr #6005,
Charlotte, North Carolina
|
|
|
Primary Sponsor
|
| Name |
Blossom Microbiotics LLC, |
| Address |
4111-E Rose Lake Dr #6005,
Charlotte, North Carolina
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apeksha Merja Patel |
NovoBliss Research Pvt. Limited |
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Gandhinagar
GUJARAT |
917948983895
consultant@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Mode of Usage: Apply a generous amo unt of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups.
Frequency: Twice a day (in the morning and before going to bed. Additionally, apply after bathing or at time of flareups/itching)
Route of Administration: Topical
Total Duration- 60 Days |
| Intervention |
SaaTwae Bio-Natural Moisturizing Cream |
Mode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups.
Frequency: Twice a day (in the morning and before going to bed. Additionally, apply after bathing or at time of flareups/itching)
Route of Administration: Topical
Total Duration: 60 Days
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age For children is 6 years and above (both inclusive) at the time of parental consent/assent and For Adults is 18 to 65 years (both inclusive) at the time of consent.
2) Sex is Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
3) Subject with TEWL more than 15 percent and Moisture level less than 20 percent at the time of screening.
4) Subject with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness is score 2) and mild scratch mark (scratching is score 1) will be enrolled into the study.
5) Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that are accessible for instrumental measurements.
6) Females of childbearing potential should have a negative urine pregnancy test at the time of screening visit.
7) Subjects (adults and children) are generally in good general health as determined from a recent medical history, except for the atopic dermatitis.
8) If subjects (adults and children) are using or taking any prescription or over the counter (OTC) medications prescribed by their physicians, they must be taking the medication for at least 4 weeks.
9) Subject and child legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skin care products during the study period.
10) Subject and child legal parent or guardian must agree to limit the sun exposure to affected areas such as arms, legs covered during prolonged sun exposure.
11) Subject and child legal parent or guardian must agree to dress the subjects in loose clothing to allow easy exposure to the entire body during study visits and throughout study duration of 60 days.
12) Subjects and Legal parent or guardian must avoid allowing the subject a hot or cold beverage within one hour of their scheduled visits and for the duration of all clinic visits, warm beverages are allowed.
13) Subjects and Legal parent or guardian must avoid allowing subject to swim or play in chlorinated water during study period.
14) Subjects are not allowed to participate in any other study until this study is complete.
15) Subjects and child legal parent or guardian must be willing and able to follow the study directions and to return for all specified visits with the subject.
16) Subjects and Child legal parent or guardian must be willing to stop using all of the subject’s normal body lotions for the duration of the study (8 weeks) and to use the provided test daily lotion as directed.
17) Subjects and Child legal parent or guardian must agree to record each use of the test products in the subject diary card on daily basis.
18) Subjects and Child legal parent or guardian must agree to record medication use during the study.
19) Subject and child legal parent or guardian must read, sign, and receive a copy of Informed Consent/Parental Informed Consent prior to initiate of study procedures.
20) Having childbearing potential, is practicing and agrees to maintain an established method of
birth control (IUD, hormonal implant device/injection, regular use of birth control pills or
patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam,
partner vasectomy or abstinence). Females will be considered as non-childbearing potential
if they are surgically sterile, have been post-menopausal for at least 1 year or have had a
tubal ligation.
21) Subjects willing to give written informed consent and are willing to come for regular follow up.
22) Subjects have not participated in a similar investigation in the past three months.
23) Subjects willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with AD on the scalp (with hair), palms, and soles.
2) Subjects with active skin infections.
3) Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis).
4) Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation.
5) Subjects with milk allergies.
6) Subjects that are pregnant and/or breastfeeding.
7) Change in current prescriptions (within 4 weeks of screening) or new and/or additional prescriptions for the skin condition (within 4 weeks of screening) or during the study.
8) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
9) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
10) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
11) Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer.
12) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data, such as 3 or more dosage or 3 or more days of anti-inflammatories (within 1 week of study enrolment) or anti-histamines and steroids.
13) The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study.
14) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
15) Pregnant or breastfeeding or planning to become pregnant during the study period.
16) History of chronic illness which may influence the cutaneous state.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI).
2. To evaluate the effectiveness of the test products in terms of changes in SCORD severity scoring, Itch Index, Eczema Area and Severity Index.
3. To evaluate the effectiveness of the test products in terms of changes in visual assessment of post inflammatory hyperpigmentation. |
from baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 (±2 Days) and Day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin |
baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| To evaluate the effectiveness of the test products in terms of changes in Visual Analogue Scale for Itching |
from baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| To evaluate the effectiveness of the test products in terms of changes in skin hydration |
from baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| To evaluate the effectiveness of the test products in terms of changes in skin barrier function |
from baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| To evaluate the effectiveness of the test products in terms of changes in skin topography |
from baseline before usage and after usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| 6. To evaluate the effectiveness of the test products by collecting skin swab from one active site |
from baseline before usage of the test products at T30 mins on Day 01, Day 30 and Day 60. |
| To evaluate the effectiveness of the test products in terms of changes in product perception questionnaire |
from baseline before usage and after usage of the test products. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an exploratory, proof-of-concept, double-blind, placebo-controlled, randomized, comparative, interventional, prospective, safety in-use tolerability and efficacy study of test products in patients with mild to moderate Atopic Dermatitis. ü Visit 01 (Day 01): Screening, Randomization, Baseline Evaluation, Post application evaluation ü Visit 02 (Day 15 ±2 Days): Test products usage, Telephonic Follow-up ü Visit 03 (Day 30 ±2 Days): Test products usage, Evaluations. ü Visit 04 (Day 60 ±2 Days): Final Evaluation, End of Study. |