Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation

This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.

Study Overview

• Status: Completed
• Conditions: Skin Health
• Intervention / Treatment: Other: Artificial Fecal Enzyme

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75062
      • Reliance Clinical Testing Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 24 Caucasian females, age 18-40, in good general health and free from dermatological conditions in the testing area.

Description

Inclusion Criteria:

• 1. 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).

  4. Caucasian individuals with Fitzpatrick skin type I, II, or III (See Appendix I).

  5. Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.

  6. Anticipated ability to complete the course of the study and to comply with instructions.

  7. Females practicing an acceptable method of birth control (abstinence is acceptable). Females of child-bearing potential must have practiced an acceptable method of birth control for the past 3 months and be willing to continue using the same method throughout the duration of the study. Acceptable methods of birth control, include: 1) Systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change the type of birth control during the study); 2) Condom with spermicide; 3) IUD; 4) Vasectomized partner; and 5) Abstinence. Females who are post-menopausal (for at least 1 year) or have had a permanent sterilization procedure (i.e. hysterectomy, tubal ligation, bilateral oophorectomy) do not need to have additional birth control methods.

Exclusion Criteria:

• 1. 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).

  2. Individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness.

  3. Individuals with recent prolonged sun or tanning bed exposure in the test area 4. Individuals with excessive dryness or redness at the sites of application. 5. Individuals with a known hypersensitivity to any of the components of the insult, controls, or adhesive tapes.

  6. Subjects must not have applied any lotions, creams, powders, or oils to their backs the morning of the study. Additionally, two hours must have passed since bathing or showering.

  7. Women who are pregnant or nursing. 8. Individuals who have participated on a study involving the test sites (back) in the previous 30 days.

  9. Individuals participating in another clinical study 10. Individuals with open or healing cuts/incisions, abrasions, lesions, pustules, fissures, or broken mucosa/skin in the test area

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema	Time for a test site to reach an erythema score of ≥ 2.	1 week
Transepidermal Water Loss (TEWL)	difference in TEWL between test sites	1 week
pH	difference in pH between test sites	1 week
Chromameter redness	difference in redness between test sites	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biophysical Measurement changes of skin capacitance	difference in capacitance between test sites	1 week
Microbiome profile	OTUs of microbiome in test site samples	1 day

Collaborators and Investigators

• Sponsor: Kimberly-Clark Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 500-17-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No