Healthy SkinPhase 4NCT00971282
Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
A Phase 4 study testing adapalen 0.1% and Cetaphil® in people with Healthy Skin, run by Galderma R&D at 1 site in Singapore.
Trial summary
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- adapalen 0.1% and Cetaphil®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2008to May 2009
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female subjects of Chinese origins
- aged 21 years or older
- with healthy skin;
Who cannot join
- skin pigmentation which interferes with the reading of skin reactions
- with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated
- with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids
- with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.
The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
Read the detailed description
The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
- Conditions
- Healthy Skin
- Being tested
- adapalen 0.1%, Cetaphil®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapalen 0.1%Drug
Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks.
Visits will be conducted weekly for a maximum of 5 visits.
Cetaphil®Other
Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks.
Visits will be conducted weekly for a maximum of 5 visits.
| Study group | Role | What they receive |
|---|---|---|
| intra-individual comparison | Experimental | Not described Receives: Drug: adapalen 0.1%; Other: Cetaphil® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema Rating Scale
score from 0 (none) to 3 (severe)
Measured: at 4 weeks
Scaling
score from 0 (none) to 3 (severe)
Measured: at 4 weeks
Dryness
score from 0 (none) to 3 (severe)
Measured: at 4 weeks
Stinging/Burning
score from 0 (none) to 3 (severe)
Measured: at 4 weeks
Pruritus
score from 0 (none) to 3 (severe)
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionMay 2009
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 Healthy SkinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr LEOW, Principal investigator, National Skin Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971282
- Sponsor's protocol ID
- RD.03.SPR.29076
- Status last verified
- Apr 2012
- First submitted
- 2 Sep 2009
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
- ClinicalTrials.gov ID
- NCT00971282
- Acronym / sponsor ID
- RD.03.SPR.29076
- Conditions
- Healthy Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Posted 15 May 2012
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 study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.
The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
Detailed description
The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-individual comparison | Experimental | Drug: adapalen 0.1%, Other: Cetaphil® |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female subjects of Chinese origins
- aged 21 years or older
- with healthy skin;
Key exclusion criteria (4 listed)
- skin pigmentation which interferes with the reading of skin reactions
- with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area to be treated
- with a washout period for the following topical treatment(s) Corticosteroids, oher anti-inflammatory drugs, retinoids
- with a washout period for the following systemic treatment(s): Medications that may increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
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 |
|---|---|---|
| adapalen 0.1%Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. | Drug | intra-individual comparison |
| Cetaphil®Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. | Other | intra-individual comparison |
Primary outcome
Erythema Rating Scale
Time frame: at 4 weeks
score from 0 (none) to 3 (severe)
Scaling
Time frame: at 4 weeks
score from 0 (none) to 3 (severe)
Dryness
Time frame: at 4 weeks
score from 0 (none) to 3 (severe)
Stinging/Burning
Time frame: at 4 weeks
score from 0 (none) to 3 (severe)
Pruritus
Time frame: at 4 weeks
score from 0 (none) to 3 (severe)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dr LEOW principal investigator
National Skin Center
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 adapalen 0.1% and Cetaphil® in people with Healthy Skin, run by Galderma R&D at 1 site in Singapore.
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 3 inclusion and 4 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 Feb 2021. 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 Singapore. 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 15 May 2012). 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?
Erythema Rating Scale (time frame: at 4 weeks). The study lists 5 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 Feb 2021.