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
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
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.
Kimberly-Clark Corporation is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of 24 Caucasian females, age 18-40, in good general health and free from dermatological conditions in the testing area.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fluent in English, willing and able to read, understand, and sign the 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).
Exclusion Criteria:
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Artificial Fecal enzyme Trypsin/Chymotrypsin mixture
Erythema
Time for a test site to reach an erythema score of ≥ 2.
Time frame: 1 week
Transepidermal Water Loss (TEWL)
difference in TEWL between test sites
Time frame: 1 week
pH
difference in pH between test sites
Time frame: 1 week
Chromameter redness
difference in redness between test sites
Time frame: 1 week
Biophysical Measurement changes of skin capacitance
difference in capacitance between test sites
Time frame: 1 week
Microbiome profile
OTUs of microbiome in test site samples
Time frame: 1 day
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.
Ran from Oct 2017 to primary completion in Oct 2017, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kimberly-Clark Corporation