Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation

Skin Health Clinical Trial

Official title:

Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346447
• Other study ID #: 500-17-06
• Status: Completed
• Phase: N/A
• First received: September 12, 2017
• Last updated: January 16, 2018
• Start date: October 9, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: January 2018
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 13, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Health

Intervention

Other:
• Artificial Fecal Enzyme
Artificial Fecal enzyme Trypsin/Chymotrypsin mixture

Locations

Country	Name	City	State
United States	Reliance Clinical Testing Services	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema	Time for a test site to reach an erythema score of = 2.	1 week
Primary	Transepidermal Water Loss (TEWL)	difference in TEWL between test sites	1 week
Primary	pH	difference in pH between test sites	1 week
Primary	Chromameter redness	difference in redness between test sites	1 week
Secondary	Biophysical Measurement changes of skin capacitance	difference in capacitance between test sites	1 week
Secondary	Microbiome profile	OTUs of microbiome in test site samples	1 day