| CTRI Number |
CTRI/2017/09/009739 [Registered on: 12/09/2017] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Skin Safety study on Healthy human subjects |
|
Scientific Title of Study
|
EVALUATION OF DERMATOLOGICAL SAFETY OF INVESTIGATIONAL PRODUCTS (06 BLEACH VARIANTS) BY SINGLE OPEN APPLICATION TEST ON ADULT HEALTHY INDIAN SUBJECTS WITH NON-SENSITIVE SKIN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
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 |
32B First Floor Rajinder Nagar Pusa Road
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
01140793385 |
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Medical Affairs & Clinical Research
Dabur Research & Development Centre
Dabur India Limited
Plot No.22,Site IV
Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Medical Affairs & Clinical Research
Dabur Research & Development Centre
Dabur India Limited
Plot No.22,Site IV
Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research & Development Centre
Dabur India Limited
Plot No.22,Site IV
Sahibabad, Ghaziabad Uttar Pradesh
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research & Development Centre Dabur India Limited Plot No.22,Site IV Sahibabad, Ghaziabad Uttar Pradesh |
| Type of Sponsor |
Other [Healthcare & FMCG] |
|
|
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 |
Dermatology Room, Department of Dermatology, 32B First Floor Rajinder Nagar Pusa Road
Central
DELHI |
01140793385
01140793385
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
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Normal Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product 1 (DRDC/2017/011): Oxylife Salon Professional Pure Oxygen Charcoal Detox Bleach
Product 2 (DRDC/2017/012):: Oxylife Salon Professional Proyouth Anti Ageing Bleach
Product 3(DRDC/2017/014):: Oxylife Salon Professional Spot Reduction Bleach Cream
Product 4 (DRDC/2017/013):: Oxylife Salon Professional Sensitive Skin Radiance Bleach
Product 5(DRDC/2017/015):: Color change bleach (Blue to White)
Product 6(DRDC/2017/016):: Color change bleach (Red to White)
|
Study will be conducted over a period of 9 days for each subject. Products will be evaluated through single open application for 30 minutes. After patch removal, skin will be observed for irritation reactions at 0 hr, 24 hr, 48 hr and 7 days post patch removal for delayed reactions |
| Comparator Agent |
Vaseline |
100µg of negative control will be applied on the test area and retained for 30 minutes,After patch removal, skin will be observed for irritation reactions at 0 hr, 24 hr, 48 hr and 7 days post patch removal for delayed reactions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy male and female subjects (in 1:1 ratio) in the age group of 18-55 years (both age inclusive) with non sensitive skin
2 Subjects representing with normal, oily, dry and combination skin type in equal ratio
3 Subjects in good general health
4 Subjects with Fitzpatrick skin phototype III to V
5 Subjects scoring less than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire
6 Subjects who agrees not to carry bleaching or any other procedures including waxing during the study period
7 Subjects able to read, understand and willing to give a voluntary written informed consent
8 Subjects willing to maintain the test patches in designated positions for a particular time duration 30 mins
9 Subjects not having participated in a similar or any other clinical trial in the past four weeks
10 Subjects willing to come for regular follow up visits
11 Subjects ready to follow instructions during the study period
12 Female subjects with child bearing potential willing to undergo Urine Pregnancy Test
|
|
| ExclusionCriteria |
| Details |
1 Subjects with known hypersensitivity to any of the study products or constituents
2 Subjects with any significant skin pathology in the investigational area
3 Subjects with skin allergy antecedents or atopic subjects
4 Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study
5 Subjects who are athletes and have a history of excessive sweating
6 Female subjects who are pregnant and lactating
7 Subjects with any significant medical condition that would interfere with the participation in the trial
8 Subjects with a present condition of allergic response to any cosmetic product
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Dermatological safety of investigational products (06 bleaching cream variants) by single open application test on adult healthy Indian subjects with non-sensitive skin |
0 hr, 24 hr, 48 hr & 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/09/2017 |
| Date of Study Completion (India) |
28/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of the study of this clinical study may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsor written approval. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. The participants will be selected from a volunteer panel
with non-sensitive skin at the study site. Twenty Four (male and female, in
equal ratio) adult subjects in the age group of 18 years to 55 years (both
inclusive) with equal representation of normal, oily, dry and combination skin
types will be selected according to inclusion and exclusion criteria. Assessment
of the irritation potential of investigational products in comparison to negative
control will be done using Draize’s scale of each product at
different time points (0 hr, 24 hrs, 48 hrs and day 7 after patch removal).
|