Skin HealthNCT03346447
Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
An observational study of Skin Health, run by Kimberly-Clark Corporation at 1 site in United States.
Trial summary
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Artificial Fecal Enzyme
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 13 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Reliance Clinical Testing Services
Irving, Texas, 75062
About this study
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.
- Conditions
- Skin Health
- Being tested
- Artificial Fecal Enzyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Fecal EnzymeOther
Artificial Fecal enzyme Trypsin/Chymotrypsin mixture
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema
Time for a test site to reach an erythema score of ≥ 2.
Measured: 1 week
Transepidermal Water Loss (TEWL)
difference in TEWL between test sites
Measured: 1 week
pH
difference in pH between test sites
Measured: 1 week
Chromameter redness
difference in redness between test sites
Measured: 1 week
Secondary outcomes (2)
Biophysical Measurement changes of skin capacitance
difference in capacitance between test sites
Measured: 1 week
Microbiome profile
OTUs of microbiome in test site samples
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start9 Oct 2017
- Primary completion27 Oct 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Reece, Principal investigator, RCTs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346447
- Sponsor's protocol ID
- 500-17-06
- Status last verified
- Jan 2018
- First submitted
- 12 Sep 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
- ClinicalTrials.gov ID
- NCT03346447
- Acronym / sponsor ID
- 500-17-06
- Conditions
- Skin Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Fecal EnzymeArtificial Fecal enzyme Trypsin/Chymotrypsin mixture | Other | – |
Primary outcome
Erythema
Time frame: 1 week
Time for a test site to reach an erythema score of ≥ 2.
Transepidermal Water Loss (TEWL)
Time frame: 1 week
difference in TEWL between test sites
pH
Time frame: 1 week
difference in pH between test sites
Chromameter redness
Time frame: 1 week
difference in redness between test sites
2 secondary outcomes
Biophysical Measurement changes of skin capacitance
Time frame: 1 week
Microbiome profile
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Reece principal investigator
RCTs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Health, run by Kimberly-Clark Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.