| CTRI Number |
CTRI/2025/07/090024 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic cream] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A simple study comparing two creams to relieve skin irritation from radiation therapy
|
|
Scientific Title of Study
|
A comparative randomized pilot study for the evaluation of two cosmetic products in patients with radiation dermatitis
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RC2024/CiCr2.0/IN/2324CICL028 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Kumar Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Action cancer hospital |
| Address |
Action Cancer Hospital A4 Block A6 Block Paschim Vihar
New Delhi India-110063
New Delhi
DELHI
110063
India |
| Phone |
9818705606 |
| Fax |
|
| Email |
cr@actioncancerhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Action cancer hospital |
| Address |
Action Cancer Hospital A4 Block A6 Block Paschim Vihar
New Delhi India-110063
New Delhi
DELHI
110063
India |
| Phone |
9818705606 |
| Fax |
|
| Email |
cr@actioncancerhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Deepika Arora |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32B First Floor Pusa Road Rajinder Nagar New Delhi
New Delhi
DELHI
110005
India |
| Phone |
9711102483 |
| Fax |
|
| Email |
d.arora@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| NAOS LES LABORATOIRES
505 rue Pierre Berthier, CS 70482, 13592 Aix-En-Provence
FRANCE |
|
|
Primary Sponsor
|
| Name |
NAOS LES LABORATOIRES |
| Address |
505 rue Pierre Berthier, CS 70482, 13592 Aix-En-Provence
FRANCE |
| 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 Manoj Kumar Sharma |
Action cancer hospital |
A4 Block A6 Block Paschim Vihar
New Delhi India 110063
East
DELHI |
9818705606
cr@actioncancerhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Action Cancer Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L589||Radiodermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CiCr2.0 tester 2 (BI008V1) |
Cosmetic cream with the composition of Aqua Water Eau Glycerin Hydroxyethyl Acrylate Sodium Acryloyldimethyl Taurate Copolymer Isohexadecane Phenoxyethanol Chlorphenesin Polysorbate 60 |
| Intervention |
Cream CiCr2.0 tester 1 |
Cosmetic cream with the composition of Aqua Water Eau Caprylic Capric Triglyceride Glycerin Polyglyceryl3 Polyricinoleate Brassica Campestris Rapeseed Seed Oil Butylene Glycol Tapioca Starch Hydrogenated Rapeseed Oil Xylose Polyglyceryl3 Diisostearate Simmondsia Chinensis Jojoba Seed Oil Magnesium Sulfate Pentylene Glycol Squalane 12Hexanediol Caprylyl Glycol Sodium Polyglutamate Sodium Citrate Xanthan Gum Sodium Hyaluronate Tocopherol Mannitol Rhamnose Xylitol Acetyl Dipeptide1 Cetyl Ester Helianthus Annuus Sunflower Seed Oil Citric Acid Fructooligosaccharides |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Subjects with a recently emerging radiodermatitis grade 1 or non oozing grade 2 according to CTCAE V5.0 and the investigator
Subjects who have started the radiotherapy sessions minimum 7 days before the inclusion of the study average time according to radiotherapist to clinically observe radiodermatitis
Subjects with a recently emerging radiodermatitis with minimum of 4 cm2 first record of appearance within 5 days prior to inclusion
Subjects undergoing radiotherapy as part of a treatment for breast cancer
Subjects undergoing external radiotherapy alone and for the first time
patients under concomitant immunotherapy are accepted
Subjects undergoing external radiotherapy for whom at least 2 weeks of radiotherapy sessions remain
Female subjects aged 18 to 65 years old both inclusive
Subjects with Phototype III to VI
Subjects under external radiotherapy after conservative surgery or mastectomy
Note Subjects who have undergone Mastectomy will be included because of the majority cases However considering the study rationale in each test group 10 subjects at least 7 subjects should be included with conservative surgery
Subjects who started external radiotherapy at least 1 month after the end of chemotherapy treatment
Subjects under standard fractionated radiotherapy regimens only external
Subjects having been informed having signed a voluntarily informed and written consent |
|
| ExclusionCriteria |
| Details |
Subjects with a radiodermatitis grade 1 or non oozing grade 2 according to CTCAE V5.0 and to the investigator having appeared more than 5 days prior to inclusion or grade 2 3 or 4 radiodermatitis according to CTCAE V5.0
Subjects with an oozing grade 2 3 or 4 radiodermatitis according to CTCAE V5.0
Subjects requiring the use of dressing for radiodermatitis
Subjects requiring a brachytherapy
Women with bilateral breast cancer
Women with cup size greater than or equal to D or with any macerative area
Pregnant or lactating women
Women of childbearing age who do not use an effective contraception Effective contraception methods typically include hormonal contraceptives intrauterine devices IUDs sterilization or strict abstinence among others
Smoking subjects more than 4 cigarettes per day
Subjects under oral anti inflammatory treatment
Subjects who are taking photosensitizing drugs such as cyclins
Subjects under local treatment or using another cosmetic product rather than the one advocated in the study
Subject with known hypersensitivity to any of the ingredients of test products
Subjects having a history of allergic contact dermatitis or irritation to any of the components of the study products
Subjects with another skin pathology that may interfere with the evaluation of a radiodermatitis at the investigators discretion
Subjects suffering from uncontrolled diabetes auto immune or micro vascular diseases
Subjects with sun exposure of the studied area during the study period
Subjects participating in another clinical study during the duration of the study
Subjects having a strongly altered general condition and or non autonomous subject using ECOG scale less than or equal to 2
Subjects who cannot understand or sign the consent form or complete study paperwork due to language barriers or mental challenges
Subjects in the impossibility of submitting to the medical follow up of the study
Subjects deprived of liberty by administrative or judicial decision or under guardianship
Any emergence of the above cited non inclusion criteria except emergence of non oozing grade 2 radiodermatitis not concerned observed during the study duration as per investigators judgement |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of the study is to evaluate and compare the cutaneous tolerance of each test
product in two groups of subjects presenting recently emerging radiodermatitis grade 1 or non oozing
grade 2 over the period of radiotherapy sessions as well as after their termination. |
Day 0
Day 14
Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check evolution of post surgery scars before and after product usage
subjective appreciation of product |
Day 0
Day 14
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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)
|
This randomized double blind clinical study aims to evaluate the efficacy and safety of two test creams CiCr20 tester 1 and 2 in preventing or managing early stage radiodermatitis grade 1 or non oozing grade 2 in 120 breast cancer patients undergoing external radiotherapy Over a 28 day period participants will apply the assigned product and undergo assessments at Day 0 14 and 28 with parameters such as skin condition radiodermatitis severity scar evolution quality of life and product tolerance measured through clinical evaluation self-assessment and instrumental tools The study excludes patients with severe dermatitis bilateral cancer ongoing use of conflicting treatments or other interfering conditions |