IrritationPhase 1NCT01105234
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
A Phase 1 study testing Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. in people with Irritation, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritation
- What is being tested?
- Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 1
- 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
- Subjects having understood and signed an informed consent form.
- Either sex
- Healthy subjects, 18 to 65 years of age
- Subjects with skin types I to IV according to Fitzpatrick Scale
- Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
Who cannot join
- Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
- Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
- Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
- Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
- Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
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- Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
- Known or suspected hypersensitivity to any component of the investigational products
- Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.
- Conditions
- Irritation
- Being tested
- Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.Drug
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriol ointment | Experimental | Not described Receives: Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical scoring of the skin reaction.
Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site)
Measured: 10 days
Secondary outcomes (1)
Transepidermal waterloss measurements
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Facy, PhD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105234
- Sponsor's protocol ID
- MCO 0901 FR
- Other IDs
- 2009-017394-38, 2009
- Status last verified
- Mar 2015
- First submitted
- 25 Feb 2010
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01105234
- Acronym / sponsor ID
- MCO 0901 FR
- Conditions
- Irritation
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Apr 2010 (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.
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcipotriol ointment | Experimental | Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects having understood and signed an informed consent form.
- Either sex
- Healthy subjects, 18 to 65 years of age
- Subjects with skin types I to IV according to Fitzpatrick Scale
- Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
Key exclusion criteria (9 listed)
- Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
- Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
- Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
- Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
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 |
|---|---|---|
| Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. | Drug | Calcipotriol ointment |
Primary outcome
Clinical scoring of the skin reaction.
Time frame: 10 days
Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site)
1 secondary outcome
Transepidermal waterloss measurements
Time frame: 10 days
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Patrice Facy, PhD study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues. in people with Irritation, run by LEO Pharma at 1 site in France.
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 9 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 24 Feb 2025. 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical scoring of the skin reaction. (time frame: 10 days). 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 24 Feb 2025.