Skin Safety study on Healthy human subjects

Completed

• Conditions: Healthy Human Normal Skin

• Registration Number: CTRI/2017/09/009739
• Lead Sponsor: Dabur India Limited

Brief Summary

1.      The participants will be selected from a volunteer panelwith non-sensitive skin at the study site. Twenty Four (male and female, inequal ratio) adult subjects in the age group of 18 years to 55 years (bothinclusive) with equal representation of normal, oily, dry and combination skintypes will be selected according to inclusion and exclusion criteria. Assessmentof the irritation potential of investigational products in comparison to negativecontrol will be done using Draize’s scale of each product atdifferent time points (0 hr, 24 hrs, 48 hrs and day 7 after patch removal).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-14
• Study Completion: 2017-09-28
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CIDP Biotech India Pvt Ltd; 🇮🇳 Central, DELHI, India

CIDP Biotech India Pvt Ltd

🇮🇳Central, DELHI, India

Dr Annie Jain

Principal investigator

01140793385

a.jain@cidp-cro.com