| CTRI Number |
CTRI/2024/04/065730 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of a test product versus a marketed product on skin in humans |
|
Scientific Title of Study
|
A monocentric, double blinded, single group, non-randomized comparative study to evaluate
in use tolerance of a test product versus marketed product in healthy participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/207/0324/STU Version No.: 1 of 14 th March 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor,27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs P Meena |
| Designation |
Head- BD & CTO |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor,27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
meena@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs P Meena |
| Designation |
Head- BD & CTO |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
| Address |
502, 5th Floor,27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
meena@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| A.Menarini India Private Limited,
2102, Tower 3, One International Center
(formerly known as Indiabulls Finance Centre),
Senapati Bapat Marg, Elphinstone Road (W),
Mumbai – 400013, India |
|
|
Primary Sponsor
|
| Name |
A.Menarini India Private Limited |
| Address |
2102, Tower 3, One International Center (formerly known as Indiabulls Finance Centre), Senapati Bapat Marg, Elphinstone Road (W), Mumbai – 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 Rajiv Joshi |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with healthy skin will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A-Ret Improvised- Tretinoin 0.1% (Test product) |
Approximately 0.03 g of the test product and control product
will be applied on test and control sites, respectively so as to cover marked area
uniformly with thin layer of product. Product application at home will be done once daily before bedtime for 30 days. |
| Comparator Agent |
A-Ret Tretinoin 0.1% (marketed product) |
Approximately 0.03 g of the test product and control product will be applied on test and control sites, respectively so as to cover marked area uniformly with thin layer of product. Product application at home will be done once daily before bedtime for 30 days. Edit || Delete
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and /or women ≥ 18 years of age.
2. 50 % Dry skin type (MoistureMeter SC Readings < 20) and 50% normal skin type.
3. Having signed a Consent Form after the study has been explained orally and in writing, of
all information concerning the study procedures and study objectives.
4. Presenting healthy skin on test sites.
5. Cooperating informed of the need and duration of the examinations. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women by UPT, Lactating mothers.
2. Allergic to any cosmetic product.
3. A participant who the Investigator feels will not be compliant with study requirements.
4. Any type of skin disorder which Investigator feels will interfere with the study
5. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the study treatment (presently or in the past 1 month). E.g. topical
steroids.
6. Chronic illness which may influence the skin sensitivity (skin problems like atopic
dermatitis, psoriasis, eczema or diseases like hypothyroidism, anaemia, hormonal
problems, or patients on anti-cholesterol drugs, etc)
7. Any cutaneous disease which would predispose to dry skin (confirmed by prior history).
8. Any cutaneous conditions on test site (scars, moles, papules etc).
9. Subject in an exclusion period or already participating in another similar cosmetic or
therapeutic trial as identified during screening on visit 1 (V1). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hydration measurements
2. TEWL measurements |
0 hour, 1 hour, 6 hour, 15 days, 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical evaluation for tolerance
2. Overall tolerance on 10 point VAS
3. Tolerance questionnaire |
1 hour, 6 hour, 15 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
25/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
Modification(s)
|
Tretinoin is also known as retinoic acid. It’s the generic name for synthetic vitamin A. It’s sold under many different brand names. Tretinoin can be a safe, effective treatment option for acne. It can also help reduce the appearance of surface wrinkles and dark spots due to sun damage. Common side effects of tretinoin include red, dry, or peeling skin, burning or itching near the application site and skin that feels warm to the touch. The test product contains an ingredient HYDROSELLA which is claimed to prevent dryness on site after application, whereas the control product does not contain any such ingredient. Hydrosella™ is an organic extract from the calyx of a unique genotype of Hibiscus sabdariffa L. It Increases organic osmolytes and their specific transporters (TauT) for higher keratinocytes water intake. It Re-hydrates dry skin cells to protect and fight against cell shrinkage caused by drying. It also Improves the skin barrier function to reduce further water loss. Clinical study conducted using single application of HYDROSELLA, in 10 female volunteers with normal to dry skin, with Single application of 1% Hydrosella™ gel on forearms, (Measurement at 1h, 24h, 48h, 72h, Skin hydration by corneometry, Skin water loss by TEWL). It was found to rapidly increases skin hydration and reduces skin water loss. Long term action, study was conducted in 10 active men, for 28 days of a gel containing of Hydrosella. Skin hydration improved by 20% & TEWL reduced by 17% compared to placebo. Therefore, this this study is planned to verify the effect of test formulation containing Hydrosella in preventing dryness of skin as compared to control tretinoin product.
Result: The study was completed with 33 complete cases and no adverse events were reported. |