Skin IrritationPhase 4NCT01892657

Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test

A Phase 4 study testing Facial Moisturizer with SPF 50+ in people with Skin Irritation, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Skin Irritation
What is being tested?: Facial Moisturizer with SPF 50+
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Aug 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men or women 18 to 70 years of age in general good health
Can read, understand, and sign informed consent

Who cannot join

History of acute or chronic disease
Diagnosed with chronic skin allergies
Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas J. Stephens and Associates, Inc.
Colorado Springs, Colorado, 89015

Other trials in United States

About this study

Official title: Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Read the detailed description

The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.

Conditions: Skin Irritation
Being tested: Facial Moisturizer with SPF 50+
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+, Hypoallergenicity, Skin Irritation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Facial Moisturizer with SPF 50+Drug
Also called Cetaphil Daily Facial Moisturizer with SPF 50+
All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+

Study groups in NCT01892657
Study group	Role	What they receive
Facial Moisturizer with SPF 50+	Experimental	All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+ Receives: Drug: Facial Moisturizer with SPF 50+

What is being measured

The primary outcome is the main question the study is designed to answer.

Area of Erythema and Elevated Responses of Skin to Product
Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.
Measured: 3 consecutive weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Aug 2008

First posted4 Jul 2013 (estimated)
Study startMar 2008
Primary completionMay 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01892657
Sponsor's protocol ID: GLI.04.SRE.US10093
Status last verified: Aug 2008
First submitted: 1 Jul 2013
Last updated: 1 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Skin Irritation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
ClinicalTrials.gov ID: NCT01892657
Acronym / sponsor ID: GLI.04.SRE.US10093
Conditions: Skin Irritation
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+, Hypoallergenicity, Skin Irritation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: May 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 4 Jul 2013 (estimated)
Results: Posted 25 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Facial Moisturizer with SPF 50+	Experimental	Drug: Facial Moisturizer with SPF 50+All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men or women 18 to 70 years of age in general good health
Can read, understand, and sign informed consent

Key exclusion criteria (3 listed)

History of acute or chronic disease
Diagnosed with chronic skin allergies
Pregnant or lactating

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
Facial Moisturizer with SPF 50+Also: Cetaphil Daily Facial Moisturizer with SPF 50+All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+	Drug	Facial Moisturizer with SPF 50+

Primary outcome

Area of Erythema and Elevated Responses of Skin to Product
Time frame: 3 consecutive weeks
Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.

Results and safety

Results posted to the registry on 25 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Facial Moisturizer With SPF 50+	128	110

Primary outcome: Area of Erythema and Elevated Responses of Skin to Product

Time frame: 3 consecutive weeks. Number. Unit: participants

Measure	Patch 1 n = 110	Patch 2 n = 110	Patch 3 n = 110	Patch 4 n = 110	Patch 5 n = 110	Patch 6 n = 110	Patch 7 n = 110	Patch 8 n = 110	Patch 9 n = 110	Challenge Patch (Original Site) - 48 Hours n = 110	Challenge Patch (Original Site) - 96 Hours n = 110	Challenge Patch (Alternate Site) - 48 Hours n = 110	Challenge Patch (Alternate Site) - 96 Hours n = 110
None	91	68	33	42	39	20	33	33	23	78	85	86	95
Mild	19	41	72	68	69	82	72	72	78	31	24	23	12
Moderate	0	1	5	0	2	8	5	5	9	1	1	1	3

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Facial Moisturizer With SPF 50+	0 of 110 (0%)	0 of 110 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Skin Irritation

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Active, not recruiting
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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.

Ronald Gottschalk, MD study director

Galderma R&D

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Facial Moisturizer with SPF 50+ 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 2 inclusion and 3 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 1 Aug 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Erythema and Elevated Responses of Skin to Product (time frame: 3 consecutive weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01892657.

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 1 Aug 2022.