Clinical trial NCT03346447: Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
Official title: Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Health
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Erythema
timeFrame: 1 week
measure: Transepidermal Water Loss (TEWL)
timeFrame: 1 week
measure: pH
timeFrame: 1 week
measure: Chromameter redness
timeFrame: 1 week
Secondary outcomes:
measure: Biophysical Measurement changes of skin capacitance
timeFrame: 1 week
measure: Microbiome profile
timeFrame: 1 day
Other outcomes:
Locations:
city: Irving
country: United States
facility: Reliance Clinical Testing Services
state: Texas
Study officials:
affiliation: RCTs
name: Barry Reece
role: PRINCIPAL_INVESTIGATOR
References: