Safety study of baby cream

Completed

• Conditions: Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (both inclusive at the time of consent).

• Registration Number: CTRI/2020/08/026966
• Lead Sponsor: Azafran Innovacion Limited

Brief Summary

This study is proposed toevaluate and establish the benefits of the test product on mildness, gentlenessand non-irritability on baby’s skin and soothes the baby’s skin, keeps thebaby’s skin moisturized post bath upon application relieving dryness and toshow the improvement in the symptoms of atopic dermatitis. During the course ofthe study, subject’s mother/ legal caretaker will record comments and opinionsabout the product in a daily diary. The proposed benefits are evaluated by the dermatologist/dermatologisttrained evaluator and assessment questionnaire at Day 1 and Day 15.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-08
• Study Completion: 2021-06-01
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 1)Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (inclusive of both genders) at the time of consent.
• 2)Babies general in good health as determined from a recent medical history 3)Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
• 4)Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
• 5)Babies should not participate in any other clinical study during participation in the current study.
• Additional Criteria for babies with atopic dermatitis: 6)Babies with mild to moderate atopic dermatitis assessed using TIS score and parental questionnaire as per dermatologist examination will be included in the study.

Exclusion Criteria

• 1)Subject’s mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / cream or any other baby face/body moisturizing product during the study period.
• 2)Chronic illness which may influence the cutaneous state.
• 3)Subject on any systemic medication.
• 4)Subject with birth defects and anomalies.
• 5)Subject participating in a similar clinical study, currently or during the previous 30 days.
• 6)Any subject, in the Investigators opinion not considered suitable for enrollment.
• 7)A known history or present condition of allergic response to any other concern that may require medical attention.
• 8)Babies with medical history (past | present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment	1.Day 01 Before application, Day 15 after application | 2.Day 01 Before application, Day 15 after application | 3.Day 01 Before application, Day 15 after application
2.The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 or Moisture Meter SC.	1.Day 01 Before application, Day 15 after application | 2.Day 01 Before application, Day 15 after application | 3.Day 01 Before application, Day 15 after application
3.To evaluate dermatological tolerability in babies with atopic dermatitis by using Three-Item Severity (TIS) Score and Parental Questionnaire	1.Day 01 Before application, Day 15 after application | 2.Day 01 Before application, Day 15 after application | 3.Day 01 Before application, Day 15 after application

Secondary Outcome Measures

Name	Time	Method
1.Subjective assessment questionnaire will be evaluated from babies’ mother/ legal caretaker. [Refer Appendix V for subjective assessment questionnaire]	1.Day 15 after application

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Nayan Patel

Principal investigator

9909013286

nkpatel@cliantha.com