Skin IrritationNCT01892423
Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion
A study testing Cetaphil Moisturizing Lotion Daily Advance in people with Skin Irritation, run by Galderma R&D at 1 site in United States.
Trial summary
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation
- What is being tested?
- Cetaphil Moisturizing Lotion Daily Advance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2006
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Good health
- willingness to cooperate and participate
- willingness to avoid topical products at test sites
- willingness to avoid direct sun exposure to test sites
Who cannot join
- Individuals with active psoriasis or eczema
- individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
- individuals who have had a mastectomy with axillary nodes were removed
- individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
- pregnant, nursing, or planned to become pregnant
- use of topical steroids or drugs at test sites
Show all 11Show fewer
- active or untreated skin cancer
- active hepatitis
- current routine or frequent use of high doses of anti-inflammatory drugs
- individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
- individuals with uncontrolled metabolic diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas J Stephens and Associates Inc
Carrollton, Texas, 75006
About this study
Official title: Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin
- Conditions
- Skin Irritation
- Being tested
- Cetaphil Moisturizing Lotion Daily Advance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetaphil Moisturizing Lotion Daily AdvanceOther
| Study group | Role | What they receive |
|---|---|---|
| Cetaphil Moisturizing Lotion Daily Advance | Experimental | Each subject had Cetaphil Moisturizing Lotion Daily Advance applied Receives: Other: Cetaphil Moisturizing Lotion Daily Advance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation responses
all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site
Measured: average of 5 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 startAug 2006
- Primary completionSep 2006
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.
- 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James H Herndon, MD, FAAD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892423
- Sponsor's protocol ID
- GLI.04SPR.US10044
- Status last verified
- Jun 2013
- First submitted
- 26 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
- Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test
- ClinicalTrials.gov ID
- NCT01892423
- Acronym / sponsor ID
- GLI.04SPR.US10044
- Conditions
- Skin Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2006 (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.
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin
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 Moisturizing Lotion Daily Advance | Experimental | Other: Cetaphil Moisturizing Lotion Daily AdvanceEach subject had Cetaphil Moisturizing Lotion Daily Advance applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Good health
- willingness to cooperate and participate
- willingness to avoid topical products at test sites
- willingness to avoid direct sun exposure to test sites
Key exclusion criteria (11 listed)
- Individuals with active psoriasis or eczema
- individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
- individuals who have had a mastectomy with axillary nodes were removed
- individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
- pregnant, nursing, or planned to become pregnant
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 Moisturizing Lotion Daily Advance | Other | Cetaphil Moisturizing Lotion Daily Advance |
Primary outcome
Irritation responses
Time frame: average of 5 weeks
all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site
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.
James H Herndon, MD, FAAD principal investigator
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 Moisturizing Lotion Daily Advance 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 11 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?
Irritation responses (time frame: average of 5 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; AzTrials last refreshed its copy on 1 Nov 2026.