| CTRI Number |
CTRI/2024/07/071520 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test product in healthy adult human subjects. |
|
Scientific Title of Study
|
A prospective, control-arm, site randomized, evaluator-blinded,
single-centre, safety, and efficacy study of Test Product “Dew Restore
Barrier Repair Cream†in healthy adult human subjects with dry and
sensitive skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240032-KE Version 1.0, 21Jun24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator-Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
office A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gujarat – India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator-Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
office A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gujarat – India
GUJARAT
382421
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 |
office A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gujarat – India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Kayura Effect LLP
1108, 11th Floor,
Salister Building,
Rajpath Rangoli Road,
SG Highway,
Ahmedabad - 380054
Gujarat- India |
|
|
Primary Sponsor
|
| Name |
Kayura Effect LLP |
| Address |
1108, 11th Floor,
Salister Building,
Rajpath Rangoli Road,
SG Highway,
Ahmedabad - 380054
Gujarat- India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
clinical trial department
Office-A - 206, 2nd
Floor, Shaligram
Lakeview Business
Complex, Near
Vaishnodevi Circle,
Khoraj.
Gandhinagar
GUJARAT
Gandhinagar
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 |
Dew Restore Barrier Repair Cream |
Test Product Name: Dew Restore Barrier Repair Cream
Product By: Kayura Effect
Dose: as required
Dosage form : semi solid
Mode of Usage: Wash the face with the gentle cleanser to remove dirt, and
oil and pat dry with the towel| tissue paper. Afterwards take the pea side
amount of the test product you finger tips, apply it over the face by small
dotes and massage it in circular motion until it is absorbed.
Frequency: Twice a Day
Route of Administration: Topical. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
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 (Preferably equal).
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 postmenopausal 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) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
5) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules)
which requires pharmaceutical or cosmeceuticals, herbal treatment.
6) 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.
7) History of alcohol or drug addiction.
8) Subjects using other marketed products during the study period.
9) Any other condition which could warrant exclusion from the study, as per the
dermatologist’s/investigator’s discretion.
10) Pregnant or breastfeeding or planning to become pregnant during the study period.
11) History of chronic illness which may influence the cutaneous state.
12) 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 effectiveness of the test product in terms of
1.change in DASI score from the baseline before and after usage of the test product.
2.change in overall dry skin score (ODS) from the baseline before and after usage of the test product.
3.change in PGA score from the baseline before and after usage of the test product.
4.change in skin hydration from the baseline before and after usage of the test product.
5.change in skin barrier function from the baseline before and after usage of the test product.
6.change in skin roughness, skin scaliness, skin smoothness and skin wrinkles from the baseline before and after usage of the test product.
|
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of the test product in terms of
1.change in desquamation index from baseline before and after usage of the test product.
2. change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness from the baseline
before and after usage of the test product.
3. subject perception questionnaire after usage of the test product from baseline before and after usage of the test product.
|
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2024 |
| 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="0"
Days="30" |
|
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 prospective, interventional, control-arm, evaluator-blinded, site randomized, single-centre, safety, and efficacy study of Test Product - “Dew Restore Barrier Repair Cream†in healthy adult human subjects with dry and sensitive skin.A total of up to 27 subjects will be enrolled to complete 25 Subjects the
study The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. There are four visits in this study. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation Visit 02 (Day 02): Evaluations, Product usage period Visit 03 (Day 15): Product Usage Period, Evaluations Visit 04 (Day 30): Evaluations, End of Study |