Atopic DermatitisPhase 2NCT03250624
Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
A Phase 2 study testing CD5024 0.3% cream in people with Atopic Dermatitis, run by Galderma R&D at 5 sites in Canada.
Trial summary
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CD5024 0.3% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Nov 2016to 26 Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participant was a male or female aged 18 to 60 years old inclusive at Screening.
- The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
- The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
- Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
- The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
- The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;
Who cannot join
- The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
- The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1.
- The participant presented with an acute flare of AD at Day 1.
- The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
- The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
- The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Galderma Investigational Site (#8581)
Mississauga, Ontario, L5H 1G9
Galderma Investigational Site (#8089)
Montreal, Quebec, H2K 4L5
Galderma Investigational Site (# 8338)
Richmond Hill, Ontario, L4B 1A5
Galderma Investigational Site (#8587)
Richmond Hill, Ontario, L4C 9M7
Galderma Investigational Site (# 8060)
Windsor, Ontario, N8W 5L7
About this study
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.
Read the detailed description
Study application was performed once daily, 7 days a week for 6 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- CD5024 0.3% cream, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5024 0.3% creamDrug
Also called Ivermectin
Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks.
PlaceboDrug
Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CD5024 0.3% cream | Experimental | Not described Receives: Drug: CD5024 0.3% cream |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).
Measured: Baseline, Day 43
Secondary outcomes (6)
Percent Change From Baseline in EASI at Each Visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.
Measured: Baseline, Days 8,15, 22, 29, 36 and 43
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.
Measured: Days 8, 15, 22, 29, 36 and 43
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit
The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.
Measured: Baseline, Days 8, 15, 22, 29, 36 and 43
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit
SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.
Measured: Baseline, Days 8, 15, 22, 29, 36 and 43
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit
Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.
Measured: Baseline, Weeks 1, 2, 3, 4, 5 and 6
Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43
Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.
Measured: Baseline, Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Nov 2016
- Primary completion26 Jun 2017
- Study completion26 Jun 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 Atopic DermatitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 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
- NCT03250624
- Sponsor's protocol ID
- RD.03.SPR.109696
- Status last verified
- Jun 2022
- First submitted
- 11 Aug 2017
- Last updated
- 1 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03250624
- Acronym / sponsor ID
- RD.03.SPR.109696
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.
Detailed description
Study application was performed once daily, 7 days a week for 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD5024 0.3% cream | Experimental | Drug: CD5024 0.3% cream |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The participant was a male or female aged 18 to 60 years old inclusive at Screening.
- The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
- The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
- Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
- The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
Key exclusion criteria (6 listed)
- The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
- The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1.
- The participant presented with an acute flare of AD at Day 1.
- The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
- The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
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 |
|---|---|---|
| CD5024 0.3% creamAlso: IvermectinParticipants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks. | Drug | CD5024 0.3% cream |
| PlaceboParticipants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
Time frame: Baseline, Day 43
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).
6 secondary outcomes
Percent Change From Baseline in EASI at Each Visit
Time frame: Baseline, Days 8,15, 22, 29, 36 and 43
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
Time frame: Days 8, 15, 22, 29, 36 and 43
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit
Time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit
Time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit
Time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43
Time frame: Baseline, Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD5024 0.3% cream in people with Atopic Dermatitis, run by Galderma R&D at 5 sites in Canada.
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 6 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 1 May 2023). 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?
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 (time frame: Baseline, Day 43). 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 1 May 2023.