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CompletedNCT03346447Updated Jan 18, 2018

Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation

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

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
23
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Skin Health
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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).

      1. Caucasian individuals with Fitzpatrick skin type I, II, or III (See Appendix I).
      1. 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.
      1. Anticipated ability to complete the course of the study and to comply with instructions.
      1. 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

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).

      1. Individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness.
      1. 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.
      1. 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.
      1. Women who are pregnant or nursing. 8. Individuals who have participated on a study involving the test sites (back) in the previous 30 days.
      1. 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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Interventions

  • OtherArtificial Fecal Enzyme

    Artificial Fecal enzyme Trypsin/Chymotrypsin mixture

05

What researchers measure

Primary outcomes

  1. Erythema

    Time for a test site to reach an erythema score of ≥ 2.

    Time frame: 1 week

  2. Transepidermal Water Loss (TEWL)

    difference in TEWL between test sites

    Time frame: 1 week

  3. pH

    difference in pH between test sites

    Time frame: 1 week

  4. Chromameter redness

    difference in redness between test sites

    Time frame: 1 week

Secondary outcomes

  1. Biophysical Measurement changes of skin capacitance

    difference in capacitance between test sites

    Time frame: 1 week

  2. Microbiome profile

    OTUs of microbiome in test site samples

    Time frame: 1 day

06

Study locations

1 site
  • Reliance Clinical Testing Services
    Irving, Texas 75062, United States
07

References and documents

Individual participant data

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.

08

Registry details

Key details

Study ID
NCT03346447
Lead sponsor
Kimberly-Clark Corporation
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Oct 9, 2017
Primary completion
Oct 27, 2017
Completion
Nov 13, 2017
Last update
Jan 18, 2018

Study contacts

Barry Reece
principal investigator · RCTs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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