| CTRI Number |
CTRI/2026/03/106706 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical safety and efficacy of a test treatments in patients having mild to moderate atopic dermatitis. |
|
Scientific Title of Study
|
An Interventional, Prospective, Three-arm Clinical Study to Assess the Safety and Efficacy of Test Treatments in AdulT Patients with Mild to Moderate Atopic Dermatitis Persisting for at Least Six Months |
| Trial Acronym |
SOOTH-AD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250061-CHL_1.0_13Feb26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Private Limited, 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheshvari Patel |
| Designation |
DIrector Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt Ltd |
| Address |
313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Chemyunion Inc.
198 Rt. 9 North, Suite 104, Manalapan
New Jersey, EUA
ZIP Code: 07726
|
|
|
Primary Sponsor
|
| Name |
Chemyunion Inc. |
| Address |
198 Rt. 9 North, Suite 104, Manalapan
New Jersey, EUA
ZIP Code: 07726
|
| Type of Sponsor |
Other [Manufacturing company] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT |
07948983895
dr.nayan@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 |
| Intervention |
Acupuncture Therapy |
Day 01,05,10,14 |
| Intervention |
Investigational Treatment Cream |
Manufactured by: Chemyunion Inc
Mode of Application: 1) The treatment should be applied to clean, dry skin, free of any other cosmetic product that the volunteer may have previously used in the area.
2) Apply one or two "pumps", spreading the treatment with the fingertips massaging the region, until the whitish appearance is reduced, preventing the spread the treatment beyond the region of interest;
IMPORTANT: The number of "pumps" per region should be decided on first use, based on the size of the affected area.
Dosage Form: Cream
Route of Administration: Topical
Duration: 14 Dyas
Frequency: 2 (twice) a day, morning and evening.
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
|
| Comparator Agent |
NIL |
N/A |
| Intervention |
Placebo Cream |
Manufactured by: Chemyunion Inc
Mode of Application: 1) The treatment should be applied to clean, dry skin, free of any other cosmetic product that the volunteer may have previously used in the area.
2) Apply one or two "pumps",spreading the treatment with the fingertips massaging the region, until the whitish appearance is reduced, preventing the spread the treatment beyond the region of interest;
IMPORTANT: The number of "pumps" per region should be decided on first use, based on the size of the affected area.
Dosage Form: Cream
Duration: 14 Days
Route of Administration: Topical
Frequency: 2 (twice) a day, morning and evening.
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 20 to 65 years at the time of consent.
2) Sex: Male and non-pregnant or non-lactating females.
3) Females of childbearing potential must have a self-reported negative pregnancy test.
4) Subject are generally in good health.
5) Subject’s with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study
6) Subjects diagnosed with mild to moderate atopic dermatitis of greater than or equal to 6 months’ duration, with at least one active lesion accessible for instrumental measurements.
7) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for atopic dermatitis in last 1 month.
8) Subjects are not allowed to participate in any other study until this study is complete.
9) Subjects willing and able to follow the study directions.
10) Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or 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.
11) Subjects willing to give written informed consent.
12) Subjects willing to use test treatment throughout the study period.
13) Subjects must agree to record each use of the test treatments in the subject’s diary card on daily basis.
14) Subjects must agree to record medication use during the study.
|
|
| ExclusionCriteria |
| Details |
1) History of any skin condition other than atopic dermatitis.
2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one month.
3) History of alcohol or drug addiction.
4) The subject has a known allergy or sensitivity to treatment ingredients.
5) 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.
6) History of other significant dermatological or systemic diseases that may interfere with study participation or data interpretation.
7) Known neurological or psychiatric disorders that could interfere with EEG assessments.
8) The subject must not have participated in a clinical study within 4 weeks prior to the pre- screening visit of this study.
9) Pregnant or breastfeeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of the test treatments by assessing change in pain and discomfort associated with atopic dermatitis within each treatment group and between treatment groups by using EEG through the Neurologist and/or Neurologist trained evaluator.
2. To evaluate the effectiveness of the test treatments by assessing change in Dry Skin/Ichthyosis Area and Severity Index (DASI) within each treatment group and between treatment groups by dermatologist trained evaluator and/or dermatologist.
3. To evaluate the effectiveness of the test treatments by assessing changes in SCORAD severity scoring, Eczema Area and Severity Index within each treatment group and between treatment groups by dermatologist trained evaluator and/or dermatologist. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test treatments by assessing change in visual and tactile assessment of skin including skin scaliness, skin roughness, skin redness, skin itchiness, skin dryness and skin smoothness within each treatment group and between treatment groups by dermatologist trained evaluator and dermatologist. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in Visual Analogue Scale for Itching within each treatment group and between treatment groups |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in skin hydration within each treatment group and between treatment groups by using Corneometer CM 825. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in skin barrier function within each treatment group and between treatment groups by using Tewameter TM Hex. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in skin topography including skin roughness, skin smoothness, skin scaliness and skin wrinkles within each treatment group and between treatment groups by using Visioscan VC 20 Plus. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in skin erythema and melanin within each treatment group and between treatment groups by using Mexameter MX 18. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in digital photography through digital camera D3300 within each treatment group and between treatment groups. |
from baseline before usage, after stimulus induction and 30 mins after test treatment usage on Day 01 and Day 14 |
| To evaluate the effectiveness of the test treatments by assessing change in Product Perception Questionnaire within each treatment group and between treatment groups. |
from before usage of test treatment on Day 01 and after usage of the test treatments at T30 mins on Day 01 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 three-arm, placebo controlled, comparative, interventional, prospective, partially-blinded, safety and efficacy study of test treatments in subjects with mild to moderate AD patients. 20 subjects in test treatment A group 20 subjects in test treatment B group, 15 subjects in test treatment C group, aged between 20 to 65 years, with mild to moderate Atopic Dermatitis for at least 6 months, will be enrolled in the study. Patients will be pre-screened by the screening department of NovoBliss Research. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Patients will be contacted telephonically by the recruiting department prior to enrolment visit. There will be total of 2 visits for test treatment A and test treatment B and total of 4 visits for test treatment C during the study. The duration of the study will be 14 Days (±2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits: Pre-screening: AD was assessed by dermatologist’s and/or Dermatologist’s trained evaluator. For test treatment A and test treatment B: Visit 01 (Day 01 ± 2 Days): Screening, Enrolment, Baseline Evaluations, Post Treatment Usage Evaluations Visit 02 (Day 14 ± 2 Days): Before Test Treatment Evaluations, Treatment Usage and Evaluations For test treatment C: Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations, Post Treatment Usage Evaluations Visit 02 (Day 05 ± 2 Days): Acupuncture therapy Visit 03 (Day 10 ± 2 Days): Acupuncture therapy Visit 04 (Day 14 ± 2 Days): Before Test Treatment Evaluations, Treatment Usage and Evaluations |