An observational study of skin hydration (Moisture) and water loss from skin on babies aged 6-24 months using diaper regularly and their mothers

Not Applicable

Completed

• Registration Number: CTRI/2012/07/002766
• Lead Sponsor: Kao Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-08-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Babies (age 6 to 24 months), with their mothers (no specific age).

Babies should be biological children of the mothers (proven by showing birth certificate).

Subjects have healthy skin.

Babies using diaper everyday, at least 2 diapers within 24 hours.

Subjects who are native Indian race (Subjectsâ?? both parents of babies are Indian and grandfather or grandmother of babies are Indian). This will be confirmed by taking history.

For whom the Investigator considers that the compliance will be correct.

Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.

Having signed a Consent Form after having been informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion Criteria

Pregnant woman confirmed via UPT.

Presence of dermatitis, dry skin, or other skin disease.

Woman having changed, started or stopped oral contraceptive or any hormonal treatment started or modified since less than 1.5 months.

Treatment of topical products containing antibiotics, retinol, or retinoic acid derivatives on measurement areas within 2 weeks before the measurement.

Genetically mixed with other races (non Indian native races) such as Chinese, Arabic, American, etc.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Skin hydration (SH) measurements using Corneometer® CM 825. <br/ ><br>2. Trans-epidermal water loss (TEWL) measurements using Tewameter® TM300. <br/ ><br>3. Digital Images using Digital Single Lens Reflex (DSLR) camera. <br/ ><br>4. Tape stripping of the stratum corneum to study intercellular lipids and proteins <br/ ><br>5. Subjective questionnaires from babiesâ?? mothers <br/ ><br>Timepoint: Day 1

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable