Psoriasis VulgarisPhase 2NCT03025282
Safety and Efficacy of CD10367 in Psoriasis Vulgaris
A Phase 2 study testing CD10367 3% Solution - Non-desquamated zone, CD10367 1% Solution - Non-desquamated zone and Betneval ointment - Non-desquamated zone in people with Psoriasis Vulgaris, run by Galderma R&D at 1 site in France.
Trial summary
This was an exploratory, single-center, investigator blinded, randomized, controlled, intra-individual study, involving participants with psoriasis vulgaris. The objective was to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- CD10367 3% Solution - Non-desquamated zone, CD10367 1% Solution - Non-desquamated zone and Betneval ointment - Non-desquamated zone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2016to 24 Mar 2017
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit.
- Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy).
- Participant had a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
- The participant had a clinical diagnosis of stable plaque psoriasis, defined as no flare during the month before Screening visit and no change between Screening visit and Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit).
- The participant presented with at least six eligible mini-zones, on at least two psoriasis plaques (Screening visit and verified also at Baseline Visit) with specific severity grades,
- Participant agreed not to wear his/her contact lenses from the Baseline visit till the D19 visit (Screening visit).
Who cannot join
- The participant presented guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).
- The participant had any uncontrolled or serious disease, or any medical or surgical condition, that might either interfere with the interpretation of the clinical trial results, and/or put the participant at significant risk (according to Investigator's judgment) if he/she participated in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).
- The participant had known or suspected allergies or sensitivities to any components of the study drugs or of the keratolytic product (see Investigator's Brochure/Product label). (Screening visit).
- The participant had known history of adverse drug reaction or hypersensitivity to a product with the same mode of action.
- The participant had any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
- The participant presented any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),
- The participant had QTc interval >450 millisecond (msec) or any abnormal electrocardiogram (ECG) value considered as clinically significant by the cardiologist (Screening visit).
- The participant had received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis
This was an exploratory, single-center, investigator blinded, randomized, controlled, intra-individual study, involving participants with psoriasis vulgaris.
The objective was to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.
Read the detailed description
Study drugs would be applied in each participant once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below:
- on 2 mini-zones pretreated by a keratolytic product, would be tested:
- CD10367 3% solution
- CD10367 solution placebo
- on 4 mini-zones non-pretreated, would be tested:
- CD10367 3% solution
- CD10367 1% solution
- CD10367 solution placebo
- Betneval 0.1% ointment
- Conditions
- Psoriasis Vulgaris
- Being tested
- CD10367 3% Solution - Non-desquamated zone, CD10367 1% Solution - Non-desquamated zone, CD10367 solution placebo - Non-desquamated zone, Betneval ointment - Non-desquamated zone, CD10367 3% Solution - Desquamated zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD10367 3% Solution - Non-desquamated zoneDrug
Once daily application for 3 weeks
CD10367 1% Solution - Non-desquamated zoneDrug
Once daily application for 3 weeks
CD10367 solution placebo - Non-desquamated zoneDrug
Once daily application for 3 weeks
Betneval ointment - Non-desquamated zoneDrug
Also called Betamethasone Valerate
Once daily application for 3 weeks
CD10367 3% Solution - Desquamated zoneDrug
Once daily application for 3 weeks
CD10367 solution placebo - Desquamated zoneDrug
Once daily application for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CD10367 3% Solution - Non-desquamated zone | Experimental | Not described Receives: Drug: CD10367 3% Solution - Non-desquamated zone |
| CD10367 1% Solution - Non-desquamated zone | Experimental | Not described Receives: Drug: CD10367 1% Solution - Non-desquamated zone |
| CD10367 solution placebo - Non-desquamated zone | Placebo comparator | CD10367 solution placebo serves as negative control. Receives: Drug: CD10367 solution placebo - Non-desquamated zone |
| Betneval ointment - Non-desquamated zone | Active comparator | This comparator containing Betamethasone valerate 0.1% serves as positive control. Receives: Drug: Betneval ointment - Non-desquamated zone |
| CD10367 3% Solution - Desquamated zone | Experimental | Not described Receives: Drug: CD10367 3% Solution - Desquamated zone |
| CD10367 solution placebo - Desquamated zone | Placebo comparator | Not described Receives: Drug: CD10367 solution placebo - Desquamated zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.
Measured: Day 1 to Day 19
Secondary outcomes (7)
Area Under the Curve (AUC) of Individual Clinical Scores
Each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) for each participant using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions. The mean AUC for each intervention was calculated for each participant.
Measured: Day 1 to Day 19
Total Sum Score (TSS) of Individual Clinical Scores
The TSS was the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). where maximum total score was 12 (worst condition) and minimum total score was 0 (no symptoms).
Measured: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Percent Change in Total Sum Score (TSS)
The TSS was the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). where maximum score was 12 (worst condition) and minimum score was 0 (no symptoms). The TSS percentage change from Day 1 at each visit and erythema, scaling and induration scores and their changes from Day 1 at each visit were evaluated by visit and by treatment received.
Measured: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Erythema, Scaling and Induration Scores at Each Visit
Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.
Measured: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.
Measured: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19
Number of Participants With Success Rate at Each Visit
Success rate was defined as a clearing score of 0 or 1, at each evaluation visit (Day 4, Day 8, Day 11, Day 15 and Day 19). The clearing score was ranged from 0 to 2, where scores were indicated as follows: 0=complete clearing (no scaling and no infiltration even on palpation. Post inflammatory hypo- or hyperpigmentation might be present, 1=almost clear (Residual erythema with some induration/infiltration [not clinically visible but palpable] without scaling, or residual erythema and residual scaling with no infiltration, 2=unchanged (unchanged or less than almost clear). Higher score indicated less success in clearing condition (worse outcome).
Measured: Day 4, Day 8, Day 11, Day 15 and Day 19
Time to First Success
The time to first success was defined as 0=no Success at any day, 1=success at Day 19 and not before, 2=success at Day 15 and not before, 3=success at Day 11 and not before, where lower score indicated less success in clearing condition (worse outcome).
Measured: Day 1 to Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start3 Nov 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
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 Psoriasis VulgarisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025282
- Sponsor's protocol ID
- RD.03.SPR.112075
- Other IDs
- 2016-002774-12, 2016
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis
- ClinicalTrials.gov ID
- NCT03025282
- Acronym / sponsor ID
- RD.03.SPR.112075
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an exploratory, single-center, investigator blinded, randomized, controlled, intra-individual study, involving participants with psoriasis vulgaris.
The objective was to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.
Detailed description
Study drugs would be applied in each participant once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below:
- on 2 mini-zones pretreated by a keratolytic product, would be tested:
- CD10367 3% solution
- CD10367 solution placebo
- on 4 mini-zones non-pretreated, would be tested:
- CD10367 3% solution
- CD10367 1% solution
- CD10367 solution placebo
- Betneval 0.1% ointment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CD10367 3% Solution - Non-desquamated zone | Experimental | Drug: CD10367 3% Solution - Non-desquamated zone |
| CD10367 1% Solution - Non-desquamated zone | Experimental | Drug: CD10367 1% Solution - Non-desquamated zone |
| CD10367 solution placebo - Non-desquamated zone | Placebo comparator | Drug: CD10367 solution placebo - Non-desquamated zoneCD10367 solution placebo serves as negative control. |
| Betneval ointment - Non-desquamated zone | Active comparator | Drug: Betneval ointment - Non-desquamated zoneThis comparator containing Betamethasone valerate 0.1% serves as positive control. |
| CD10367 3% Solution - Desquamated zone | Experimental | Drug: CD10367 3% Solution - Desquamated zone |
| CD10367 solution placebo - Desquamated zone | Placebo comparator | Drug: CD10367 solution placebo - Desquamated zone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit.
- Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy).
- Participant had a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
- The participant had a clinical diagnosis of stable plaque psoriasis, defined as no flare during the month before Screening visit and no change between Screening visit and Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit).
- The participant presented with at least six eligible mini-zones, on at least two psoriasis plaques (Screening visit and verified also at Baseline Visit) with specific severity grades,
Key exclusion criteria (8 listed)
- The participant presented guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).
- The participant had any uncontrolled or serious disease, or any medical or surgical condition, that might either interfere with the interpretation of the clinical trial results, and/or put the participant at significant risk (according to Investigator's judgment) if he/she participated in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).
- The participant had known or suspected allergies or sensitivities to any components of the study drugs or of the keratolytic product (see Investigator's Brochure/Product label). (Screening visit).
- The participant had known history of adverse drug reaction or hypersensitivity to a product with the same mode of action.
- The participant had any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
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 |
|---|---|---|
| CD10367 3% Solution - Non-desquamated zoneOnce daily application for 3 weeks | Drug | CD10367 3% Solution - Non-desquamated zone |
| CD10367 1% Solution - Non-desquamated zoneOnce daily application for 3 weeks | Drug | CD10367 1% Solution - Non-desquamated zone |
| CD10367 solution placebo - Non-desquamated zoneOnce daily application for 3 weeks | Drug | CD10367 solution placebo - Non-desquamated zone |
| Betneval ointment - Non-desquamated zoneAlso: Betamethasone ValerateOnce daily application for 3 weeks | Drug | Betneval ointment - Non-desquamated zone |
| CD10367 3% Solution - Desquamated zoneOnce daily application for 3 weeks | Drug | CD10367 3% Solution - Desquamated zone |
| CD10367 solution placebo - Desquamated zoneOnce daily application for 3 weeks | Drug | CD10367 solution placebo - Desquamated zone |
Primary outcome
Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
Time frame: Day 1 to Day 19
The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.
7 secondary outcomes
Area Under the Curve (AUC) of Individual Clinical Scores
Time frame: Day 1 to Day 19
Total Sum Score (TSS) of Individual Clinical Scores
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Percent Change in Total Sum Score (TSS)
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Erythema, Scaling and Induration Scores at Each Visit
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19
Number of Participants With Success Rate at Each Visit
Time frame: Day 4, Day 8, Day 11, Day 15 and Day 19
Time to First Success
Time frame: Day 1 to Day 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD10367 3% Solution - Non-desquamated zone, CD10367 1% Solution - Non-desquamated zone and Betneval ointment - Non-desquamated zone in people with Psoriasis Vulgaris, run by Galderma R&D 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 6 inclusion and 8 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Sep 2024). 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 Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) (time frame: Day 1 to Day 19). 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 19 Sep 2024.