Atopic DermatitisPhase 2NCT00919763
Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
A Phase 2 study testing CD2027 Ointment 3 mcg/g, twice daily in people with Atopic Dermatitis, run by Galderma R&D at 14 sites in United States.
Trial summary
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CD2027 Ointment 3 mcg/g, twice daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 14 sitesUnited States
- Study dates
- 21 May 2009to 1 Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant, 18 years of age or older
- Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3)
- Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck
- At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
Who cannot join
- The participant had albumin-adjusted calcium above the upper normal range from screening evaluation
- The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
- The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Research Center, Inc.
Arlington, Texas, 76011
DermResearch Inc.
Austin, Texas, 78759
J&S Studies, Inc.
College Station, Texas, 77845
Colorado Medical Research Center, Inc.
Denver, Colorado, 80120
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Longmont Medical Research Network
Longmont, Colorado, 80501
Dermatology Specialists PSC
Louisville, Kentucky, 40202
International Dermatology Research, Inc.
Miami, Florida, 33144
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
Helendale Dermatology & Medical Spa, LLC
Rochester, New York, 104609
Therapeutics Clinical Research, Inc.
San Diego, California, 92123
About this study
Official title: A Four-Week, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CD2027 Ointment 3 mcg/g Twice Daily in the Treatment of Adults With at Least Moderate Atopic Dermatitis
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- CD2027 Ointment 3 mcg/g, twice daily, Vehicle Ointment, twice daily
- Keywords
- Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD2027 Ointment 3 mcg/g, twice dailyDrug
Topical Ointment
Vehicle Ointment, twice dailyDrug
Topical Ointment
| Study group | Role | What they receive |
|---|---|---|
| CD2027 Ointment 3 mcg/g, twice daily | Experimental | Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. Receives: Drug: CD2027 Ointment 3 mcg/g, twice daily |
| Vehicle Ointment, twice daily | Placebo comparator | Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. Receives: Drug: Vehicle Ointment, twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4
TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition.
Measured: Baseline, Week 4
Secondary outcomes (3)
Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4
TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (Worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Data for individual signs is reported in this outcome measure. Lower score meant improvement in condition and higher score indicated severity (worsening of condition) for each individual sign.
Erythema was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Excoriation evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Exudation was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Lichenification was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Pruritus was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe).
Measured: Baseline, Week 4
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4
IGA was an assessment scale used to determine severity of Atopic Dermatitis (AD) and clinical response to treatment on a 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a failure from baseline of greater than (>1) points over 4 weeks were reported.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4
The EASI score quantifies the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no eruption) to 6 (>90%-100% eruption). The total score was the sum of the four body-region scores, maximum=72, minimum=0, Higher scores indicated greater disease severity.
Measured: Baseline, Week1, Week2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study start21 May 2009
- Primary completion1 Oct 2009
- Study completion1 Oct 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919763
- Sponsor's protocol ID
- RD.06.SPR.18158
- Status last verified
- May 2022
- First submitted
- 9 Jun 2009
- Last updated
- 19 Jul 2022
- 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 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Week, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CD2027 Ointment 3 mcg/g Twice Daily in the Treatment of Adults With at Least Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00919763
- Acronym / sponsor ID
- RD.06.SPR.18158
- Conditions
- Atopic Dermatitis
- Keywords
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 21 May 2009 (actual)
- Primary completion
- 1 Oct 2009 (actual)
- Study completion
- 1 Oct 2009 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 1 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 was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD2027 Ointment 3 mcg/g, twice daily | Experimental | Drug: CD2027 Ointment 3 mcg/g, twice dailyParticipants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
| Vehicle Ointment, twice daily | Placebo comparator | Drug: Vehicle Ointment, twice dailyParticipants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participant, 18 years of age or older
- Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3)
- Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck
- At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
Key exclusion criteria (3 listed)
- The participant had albumin-adjusted calcium above the upper normal range from screening evaluation
- The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
- The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the 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 |
|---|---|---|
| CD2027 Ointment 3 mcg/g, twice dailyTopical Ointment | Drug | CD2027 Ointment 3 mcg/g, twice daily |
| Vehicle Ointment, twice dailyTopical Ointment | Drug | Vehicle Ointment, twice daily |
Primary outcome
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4
Time frame: Baseline, Week 4
TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition.
3 secondary outcomes
Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4
Time frame: Baseline, Week 4
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4
Time frame: Baseline, Week1, Week2, Week 3, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Michael Graeber, MD study director
Galderma R&D
14 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 CD2027 Ointment 3 mcg/g, twice daily in people with Atopic Dermatitis, run by Galderma R&D at 14 sites 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 4 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. 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 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?
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 (time frame: Baseline, Week 4). 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 Jul 2022.