To study the safety of test product on skin in humans.
- Registration Number
- CTRI/2022/12/048355
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
a) Voluntary men and women (preferably equal number of males and females) between 18
and 65 years having sensitive skin in nasolabial area as determined by lactic acid sting
test.
b) Fitzpatrick skin type III to IV.
c) Having apparently healthy skin on test area.
d) Willingness to discontinue the use of cleansing and/or cosmetic products in the application
areas during the course of the trial.
e) Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
f) Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
g) Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
h) Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, saunaâ?¦), during the course of the trial.
i) Should be able to read and write (in English, Hindi, or local language).
j) Ready to wear loose cotton clothes
k) Having valid proof of identity and age.
l) Subject having not participated in another trial in the past one month.
a) Pregnancy (by UPT) and lactating women.
b) Scars, excessive terminal hair, tattoo, cuts, wounds, irritation symptoms, abrasion, or any
other skin condition on the studied area.
c) Athletes and subjects with history of excessive sweating.
d) Subjects on oral corticosteroid.
e) Any history of underlying uncontrolled medical illness including diabetes, liver disease or
history of alcoholism, HIV, or any other serious medical illness.
f) A participant who the Investigator feels will not be compliant with trial requirements
g) Dermatological infection/pathology on the level of studied area.
h) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
i) Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
j) Chronic illness which may influence the outcome of the trial.
k) Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
l) Participant in an exclusion period or participating in another food, cosmetic or therapeutic
trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of cutaneous tolerance of skin reactionsTimepoint: 48 hours
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil