Skin IrritationNCT01892410
Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash
A study testing Cetaphil Restoraderm Skin Restoring Body Wash in people with Skin Irritation, run by Galderma R&D at 1 site in United States.
Trial summary
Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation
- What is being tested?
- Cetaphil Restoraderm Skin Restoring Body Wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not currently under a doctor's care
- Free of dermatological or systemic disorder which would interfere with the results
- Free of any acute or chronic disease
- Will complete a preliminary medical history form and are in general good health
- Can read, understand, and sign informed consent
Who cannot join
- Under 18 years old
- Currently under doctor's care
- Currently taking any medication
- History of acute or chronic disease
- Diagnosed with chronic skin allergies
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)
Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.
- Conditions
- Skin Irritation
- Being tested
- Cetaphil Restoraderm Skin Restoring Body Wash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetaphil Restoraderm Skin Restoring Body WashOther
Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cetaphil Restoraderm Skin Restoring Body Wash | Experimental | All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion Receives: Other: Cetaphil Restoraderm Skin Restoring Body Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of irritation measured to determine sensitivity
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin IrritationStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayya Tastene, MD, Principal investigator, AMA Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892410
- Sponsor's protocol ID
- GLI.04.SRE.US10235
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)
- ClinicalTrials.gov ID
- NCT01892410
- Acronym / sponsor ID
- GLI.04.SRE.US10235
- Conditions
- Skin Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 4 Jul 2013 (estimated)
- 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.
Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetaphil Restoraderm Skin Restoring Body Wash | Experimental | Other: Cetaphil Restoraderm Skin Restoring Body WashAll subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Not currently under a doctor's care
- Free of dermatological or systemic disorder which would interfere with the results
- Free of any acute or chronic disease
- Will complete a preliminary medical history form and are in general good health
- Can read, understand, and sign informed consent
Key exclusion criteria (6 listed)
- Under 18 years old
- Currently under doctor's care
- Currently taking any medication
- History of acute or chronic disease
- Diagnosed with chronic skin allergies
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 |
|---|---|---|
| Cetaphil Restoraderm Skin Restoring Body WashDiluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks | Other | Cetaphil Restoraderm Skin Restoring Body Wash |
Primary outcome
Area of irritation measured to determine sensitivity
Time frame: 3 weeks
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
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 29 Jul 2022.
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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.
Mayya Tastene, MD principal investigator
AMA Laboratories, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetaphil Restoraderm Skin Restoring Body Wash in people with Skin Irritation, run by Galderma R&D 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 29 Jul 2022. 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?
Area of irritation measured to determine sensitivity (time frame: 3 weeks). 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 29 Jul 2022.