Itching SymptomsNCT01806935
Xerotic Dermatitis in Aged People
A study testing DC086 in people with Itching Symptoms and Xerotic Dermatitis, run by Pierre Fabre Medical Devices at 14 sites in France.
Trial summary
The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Itching Symptoms, Xerotic Dermatitis
- What is being tested?
- DC086
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 14 sitesFrance
- Study dates
- Apr 2013to Sep 2013
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged from 70 years
- With xerotic dermatitis, clinically assessed ,
- At least on the anterior part of lower and/or upper limbs,
- Presenting itching xerotic dermatitis evolving from at least 3 weeks
- Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
- With MMSE score ≥ 20 dating less than 6 months
- Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)
Who cannot join
- Criteria related to pathologies
- Severe form of other dermatitis requiring either systemic treatment
- -- Itching xerotic dermatitis from iatrogenic origins
- Dermatological disease other than xerotic dermatitis which could interfere with the assessment,
- Systemic disease that may generate xerotic dermatitis and /or pruritus
- Immunosuppression condition,
Show all 12Show fewer
- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
- Criteria related to treatment
- Use of treatment which could interfere with the evaluation of the disease or the course of the disease
- Criteria related to the population
- Ongoing participation to another clinical trial or participation in the previous month before the inclusion
- Patient under guardianship or trusteeship
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
0521
Angers
0523
Angers
0520
Cugnaux
0517
Le Fousseret
0518
Muret
0519
Muret
0515
Saint-Orens-de-Gameville
0516
Saint-Orens-de-Gameville
0511
Seysses
0512
Seysses
0513
Seysses
0514
Seysses
0522
Tiercé
0501
Toulouse
About this study
The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population
- Conditions
- Itching Symptoms, Xerotic Dermatitis
- Being tested
- DC086, Placebo
- Keywords
- associated, aged population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC086Device
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| DC086 | Experimental | cream Receives: Device: DC086 |
| placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itching symptoms intensity change
Measured: From Day 1 to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Itching SymptomsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Rolland, Principal investigator, Hôpital Purpan CHU TOULOUSE, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806935
- Sponsor's protocol ID
- 2012-A01547-36
- Status last verified
- Feb 2013
- First submitted
- 6 Mar 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xerotic Dermatitis in Aged People
- ClinicalTrials.gov ID
- NCT01806935
- Acronym / sponsor ID
- 2012-A01547-36
- Conditions
- Itching Symptoms, Xerotic Dermatitis
- Keywords
- associated, aged population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Pierre Fabre Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Mar 2013 (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 the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC086 | Experimental | Device: DC086cream |
| placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged from 70 years
- With xerotic dermatitis, clinically assessed ,
- At least on the anterior part of lower and/or upper limbs,
- Presenting itching xerotic dermatitis evolving from at least 3 weeks
- Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
Key exclusion criteria (12 listed)
- Criteria related to pathologies
- -- Itching xerotic dermatitis from iatrogenic origins
- Criteria related to treatment
- Criteria related to the population
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 |
|---|---|---|
| DC086 | Device | DC086 |
| Placebo | Device | placebo |
Primary outcome
Itching symptoms intensity change
Time frame: From Day 1 to 28 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 26 Sep 2013.
Related trials for Itching Symptoms
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Not yet recruitingEarly Phase 1
Topical Minocycline for CARP
Confluent and Reticulated Papillomatosis (CARP)
Not yet recruitingObservational study
A Study to Learn About the Study Medicine Abrocitinib in People With Severe Atopic Dermatitis Who Have Switched From Other Therapies
Dermatitis, Atopic
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
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.
Yves Rolland principal investigator
Hôpital Purpan CHU TOULOUSE, France
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DC086 in people with Itching Symptoms and Xerotic Dermatitis, run by Pierre Fabre Medical Devices at 14 sites 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 7 inclusion and 12 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 26 Sep 2013. 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 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.
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?
Itching symptoms intensity change (time frame: From Day 1 to 28 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 26 Sep 2013.