An observational study in Skin Health, sponsored by Kimberly-Clark Corporation. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Kimberly-Clark Corporation · Observational
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
Biophysical measurements will be taken at each test sites.
The study population consists of 24 Caucasian females, age 18-40, in good general health and free from dermatological conditions in the testing area.
Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF) 2. Ability to complete the course of the study and comply with instructions; 3. Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required).
Exclusion Criteria:
Individuals with any visible skin disease, skin condition (e.g., back acne) including baseline erythema assessment > 0.5, or tattoos in the test area (mid to upper back).
Artificial Fecal enzyme Trypsin/Chymotrypsin mixture
Erythema
Time for a test site to reach an erythema score of ≥ 2.
Time frame: 1 week
Transepidermal Water Loss (TEWL)
difference in TEWL between test sites
Time frame: 1 week
pH
difference in pH between test sites
Time frame: 1 week
Chromameter redness
difference in redness between test sites
Time frame: 1 week
Biophysical Measurement changes of skin capacitance
difference in capacitance between test sites
Time frame: 1 week
Microbiome profile
OTUs of microbiome in test site samples
Time frame: 1 day
Plan to share: No — Subjects will be identified on CRFs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Kimberly-Clark Corporation