| CTRI Number |
CTRI/2021/10/037231 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Moisturiser] |
| Study Design |
Other |
|
Public Title of Study
|
A Monocentric, Randomized, blinded, controlled study to evaluate the efficacy of Excella Max Moisturiser. |
|
Scientific Title of Study
|
A Monocentric, Assesor Blind, Randomized, Controlled, Before And After Use Clinical Study To Evaluate And Compare The Efficacy Of Topically Applied Moisturizer In Improving Symptoms Associated With Cutaneous Xerosis On The Legs, Over A Period Of 4 Weeks |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2021CICL027 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
Central
DELHI
110005
India |
| Phone |
9582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
Central
DELHI
110005
India |
| Phone |
9582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Meenakshi Kafaltia |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi
Central
DELHI
110005
India |
| Phone |
9873265295 |
| Fax |
|
| Email |
pm.in@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| CIDP Biotech India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
CIPLA LTD
Cipla House Peninsula Business Park Ganpatrao
KadamMarg Lower Parel Mumbai-400013 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 Annie Jain |
CIDP Biotech India Pvt Ltd |
32 B First Floor Rajinder Nagar Pusa Road New Delhi
Central
DELHI |
9582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee-ACEAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with Cutaneous Xerosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Excela Max Moisturiser |
Evaluate And Compare The Efficacy Of Topically Applied Moisturizer In Improving Symptoms Associated With Cutaneous Xerosis On The Legs at Day 0 and Day 27
Frequency: Moisturizer will be applied twice daily (morning and evening after bathing/washing). Keep at least a gap of 10-12 hrs. between morning and evening moisturizer usage
Dosage: Dosage Form: Moisturizer
Dosage: Product application will be done on the treatment area i.e., assigned leg, twice a day.
To be used in sufficient quantity to cover the entire treatment area i.e., assigned leg.
Total Duration of treatment: 28 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 1. Subjects with clinical diagnosis of skin xerosis associated with symptoms and signs such as erythema, desquamation, pruritus/itching, lichenification etc. (as verified by the Investigator using ODS scoring and SRRC Grading)
2.Subjects between 18-65 years (both inclusive) of age.
3. Subjects with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
4. Subjects free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions that as per the investigator could interfere with interpretation of the data.
5. Subjects willing not to use any other soap/cleanser/cream/lotion/perfume/any skin care products/any other treatments on the affected area during the study, except investigational product and their own regular cleanser.
6. Subjects willing not to remove hair of the affected area by waxing/shaving/using stone/etc or any depilatory (hair removing) within 3 days before the scheduled study visit.
7. Subject willing and able to fulfil the study requirements and schedule
8. Subject willing to provide written informed consent and are able to read, speak, write, and understand English or Hindi or any other vernacular language.
9. Female of childbearing potential willing to undergo urine pregnancy test [self-declared by subject on screening visit and test to be done on Visit 2, Baseline visit (Day 0) and Visit 6, Day 28]
10. Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant or lactating or who are planning to become pregnant during the study.
2.Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study.
3.Subjects having known hypersensitivity to the study product or its constituents.
4.Any significant medical condition that would interfere with the participation in the trial, as per opinion of the Investigator.
5.Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator.
6.Any topical or systemic treatment which in the opinion of the investigator might counter or influence the trial aim within the last 4 weeks prior to participation in the study and during the study.
7.Subjects with any of the following conditions present on the test area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, ulcers and wounds.
8.Having participated in the last 30 days before screening or currently participating in another clinical study.
9.Unable to be contacted by phone in case of emergency.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the moisturizing efficacy and safety of the investigational product in improving the symptoms associated with cutaneous xerosis, in comparison to the baseline and non-treated control site, using the following:
1. The clinical scoring systems of EEMCO Guidance to evaluate visual signs of skin dryness:
➢ Overall Dry Skin Score (ODS).
➢ Specified Symptom Sum Score (SRRC Grading for Scaling, Roughness, Redness & Cracks).
2. Subject evaluation of itch/pruritus severity using the 11-point NRS itch scale.
3. Evaluation of Skin Hydration using Corneometer CM 825®/MPA.
4. Evaluation of TEWL (Trans epidermal water loss) using Tewameter. |
Day 1 7 14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self-Assessment Questionnaire at Day 1, Day 7, Day 14 & Day 28 as compared to Day 0.
• Safety will be assessed by recording adverse events, including cutaneous reactions related to the investigational products (cutaneous acceptability) throughout the study duration (in treatment phase).
• Compare the safety events reported i.e., AE, SAE, LI data of the treatment site and the control site. |
Day 1 7 14 and 28 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
13/10/2021 |
| Date of Study Completion (India) |
10/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims at evaluating and comparing the moisturizing efficacy and safety of the Excela Max Moisturiser in improving the symptoms associated with cutaneous xerosis, in comparison to the baseline and nontreated control site, using the following: 1. The clinical scoring systems of EEMCO Guidance to evaluate visual signs of skin dryness: ➢ Overall Dry Skin Score (ODS). ➢ Specified Symptom Sum Score (SRRC Grading for Scaling, Roughness, Redness & Cracks). 2. Subject evaluation of itch/pruritus severity using the 11-point NRS itch scale. 3. Evaluation of Skin Hydration using Corneometer CM 825®/MPA. 4. Evaluation of TEWL (Trans epidermal water loss) using Tewameter. |