| CTRI Number |
CTRI/2024/11/077124 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test products in healthy adult human subjects with dry and sensitive skin. |
|
Scientific Title of Study
|
An exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240044-GL, 1.0 20 Oct 24 |
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 |
Principal Investigator
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - .
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| 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 |
Principal Investigator
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - .
GUJARAT
382481
India |
| Phone |
9909013286 |
| 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 |
Principal Investigator
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - .
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Glowderma Lab Private Limited
3rd floor, iconic Tower,
Urmi Estate, Ganparao Kadam Marg,
Nagin Nagar Chawal,
Lower Parel West, Lower Parel- 400013, India
|
|
|
Primary Sponsor
|
| Name |
Glowderma Lab Private Limited |
| Address |
3rd floor, iconic Tower,
Urmi Estate, Ganparao Kadam Marg,
Nagin Nagar Chawal,
Lower Parel West, Lower Parel- 400013, India
|
| 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 Nayan Patel |
NovoBliss Research Pvt. Limited |
Office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Clinical Trial Department Office 313.
Ahmadabad
GUJARAT |
9909013286
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 |
| Healthy Human Volunteers |
Dry and Sensitive Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moiz LMF 48 |
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed.
Manufactured By: Dermalogics
Marketed By: Glowderma Lab Private Limited
Frequency: Twice a Day or as often as needed
Route of Administration: Topical
Total Duration- 60 Days |
| Intervention |
Moiz MM |
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed.
Manufactured By: Dermalogics
Marketed By: Glowderma Lab Private Limited
Frequency: Twice a Day
Route of Administration: Topical
Total Duration- 60 Days
|
| Intervention |
Moiz XL |
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed.
Manufactured By: Dermalogics
Marketed By: Glowderma Lab Private Limited
Frequency: Twice a Day
Route of Administration: Topical
Total Duration- 60 Days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 55 years (both inclusive) at the time of consent.
2) Sex: Healthy male and non-pregnant/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 with dry and sensitive skin at a time of screening. (Dermatological Assessment)
6) Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites.
7) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
8) If the subject is of 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.
9) Subjects are willing to give written informed consent and are willing to come for regular follow up.
10) Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
11) Subject who have not participated in a similar investigation in the past three months.
12) Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1) History of any dermatological condition of the skin diseases.
2) Subject with present condition of allergic response to any cosmetic product.
3) Subject having allergic response to the ink.
4) any areas of broken/chapped/cut/irritated/scraped skin.
5) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
6) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment.
7) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
8) History of alcohol or drug addiction.
9) Subjects using other marketed products during the study period.
10) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
11) Pregnant or breastfeeding or planning to become pregnant during the study period.
12) History of chronic illness which may influence the cutaneous state.
13) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and effectiveness of test product in terms of change in :
1. skin hydration
2. DASI score
3. overall dry skin score
4. skin barrier function
5. skin roughness, skin scaliness, skin smoothness, and skin wrinkles. |
from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the test product in terms of change in desquamation index |
from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60. |
| To assess the effectiveness of the test product in terms of change in PGA score |
score from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60. |
| To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness |
from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60. |
| To assess the effect of the test products in terms of product perception |
after usage of the test products from baseline before usage of the test product on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08, Day 30 and Day 60. |
| Safety will be determined by product-emergent adverse events such as stinging, burning, irritation, dryness, or redness at the application site assessed by the Dermatologist/Study Physician. |
on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 , Day 30 and Day 60. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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 Yet Recruiting |
| 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 exploratory, prospective,
open-label, randomized, three-arm, single-centre, safety, efficacy and
in-use tolerability study of the three different test products in healthy adult
human subjects with dry and sensitive skin. -
Visit 01 : Screening, Enrolment, Baseline
Evaluation, On Site Product Usage, Post Usage Evaluation
-
Visit 02 : Evaluations, Product usage period
-
Visit 03 : Product Usage Period, Evaluations
-
Visit 04 : Evaluations, End of Study |