| CTRI Number |
CTRI/2024/10/074783 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy check of Tatshan After Sun recovery Gel for sunburn |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Tatshan After Sun recovery Gel in Reducing Erythma and Inflammation after UV-B Exposure on skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 282 Version 1.0 dated 08 Aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Ramanathan |
| Designation |
Consultant |
| Affiliation |
MOHB GROWELL PRIVATE LIMITED |
| Address |
NEW NO.19 OLD NO.9, ground Floor, Derma Dept, VELAYUDAM STREET, NUNGAMBAKKAM, Chennai, Tamil Nadu, 600034
Chennai
TAMIL NADU
600034
India |
| Phone |
9444403001 |
| Fax |
|
| Email |
mohbgrowellchennai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Ramanathan |
| Designation |
Consultant |
| Affiliation |
MOHB GROWELL PRIVATE LIMITED |
| Address |
NEW NO.19 OLD NO.9, ground Floor, Derma Dept, VELAYUDAM STREET, NUNGAMBAKKAM, Chennai, Tamil Nadu, 600034
Chennai
TAMIL NADU
600034
India |
| Phone |
9444403001 |
| Fax |
|
| Email |
mohbgrowellchennai@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, First floor, 135, Delhi Rd, besides Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh 250002 |
| Mohb Growell Pvt Ltd, New no19, Velayudam St.Nungam Bakkam Chennai, 600034 |
|
|
Primary Sponsor
|
| Name |
Mohb Growell Pvt Ltd |
| Address |
New no19, Velayudam St.Nungam Bakkam Chennai, 600034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
7078103723
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aloevera Gel |
Approx 0.25gm gel to be applied on one of the irradiated skin patch 3.
Route of administration: Topical
Frequency: Twice a day Duration: 7 days |
| Comparator Agent |
Blank |
No Product Applied
Frequency: None
Duration: 7 days |
| Comparator Agent |
Calamine and Liquid paraffin Lotion |
Approx 0.25gm to be applied on one of the irradiated skin patch 2.
Route of administration: Topical
Frequency: Twice a day Duration: 7 days |
| Intervention |
Tatshan Aftersun Recovery Gel |
Approx 0.25gm gel to be applied on one of the irradiated skin patch 1.
Route of administration: Topical
Frequency: Twice a day
Duration: 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Having apparently healthy skin on test area, for whom the investigator considers that the compliance will be correct and who can allow irradiation slightly more than the MED.
2. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
4. Having signed a Consent form.
5. Should be able to read and write (in English, Hindi or local language).
6. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
7.Chronic illness which may influence the outcome of the study
8.Subjects 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)
9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Erythema with Mexameter |
Day 2, Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in redness with colorimeter |
Day 2, Day 7 |
| Change in Edema by Dermat |
Day 2, Day 7 |
| Change in skin Temperature |
Day 2, Day 7 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="3"
Days="0" |
|
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
|
To Evaluate the efficacy of a gel containing extract of phormidium persinicum , glyceryl glucoside ,beta glycirhettinic acid , natural alpha bisobolol in reducing erythema after UVB exposure.
To evaluate its utility in treatment of sunburns
Day0: MED at three spots. send the volunteers with the test creams. ask them to apply the said creams twice a day for 7 days . as the volunteers to apply
patch 1 test cream twice a day patch 2 Calamine and liquid paraffin lotion twice a day patch 3 Aloevera Gel twice a day Patch 4 Blank
Day 2: once the redness is visible
- measure redness with colorimeter , pigment - Mexameter, edema by Dermat, temperature - dedicated skin temperature probe-
Pain- questionnaire, Imaging
Day 3: a followup call for redness, pain
Day 7: Same as Day 2 assessments
|