AcnePhase 4NCT02307266

Patient Education in Adherence on Acne (PEAce)

A Phase 4 study of Acne, run by Galderma R&D at 10 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 10 sitesUnited Kingdom
Study dates: Nov 2014to Jun 2015
Phase: Phase 4
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female subjects age of 12 years or older,
With facial acne vulgaris that can be managed in primary care

Who cannot join

Female subjects who are pregnant, nursing or planning a pregnancy during the study,
Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United Kingdom10 sites

Swan Lane Medical Centre
Bolton
Burbage Surgery
Burbage
South Axholme Practice
Epworth
Dr Moss and Partners
Harrogate
Barlow Medical Centre
Manchester
Leicester Terrace Health Care Centre
Northampton
University of Nottingham Health Service
Nottingham
Rothwell and Desborough Healthcare Group
Rothwell
Albany House Medical Centre
Wellingborough
Whitby Group Practice
Whitby

Other trials in United Kingdom

About this study

Official title: Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics

Conditions: Acne
Being tested: Standard of care + supplementary education, Standard of care + additional visits, Standard of care
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard of care + supplementary educationBehavioural
Standard of care + additional visitsBehavioural
Standard of careBehavioural

Study groups in NCT02307266
Study group	Role	What they receive
Standard of care + supplementary education	Experimental	Subjects will receive supplementary patient educational material in addition to standard-of-care instructions. Receives: Behavioral: Standard of care + supplementary education
Standard of care	Experimental	Subjects will receive standard-of-care instructions only. Receives: Behavioral: Standard of care
Standard of care + additional visits	Experimental	Subjects will receive standard-of-care instructions, and two additional clinical visits. Receives: Behavioral: Standard of care + additional visits

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.
Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jun 2015

First posted4 Dec 2014 (estimated)
Study startNov 2014
Primary completionJun 2015
Study completionJun 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AcneStudies 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 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02307266
Sponsor's protocol ID: RD.03.SPR.102710
Status last verified: Jul 2016
First submitted: 26 Nov 2014
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Myhill T, Coulson W, Nixon P, Royal S, McCormack T, Kerrouche N. Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study. Dermatol Ther (Heidelb). 2017 Dec;7(4):515-524. doi: 10.1007/s13555-017-0203-4. Epub 2017 Oct 12.
PubMed 29027127

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics
ClinicalTrials.gov ID: NCT02307266
Acronym / sponsor ID: RD.03.SPR.102710
Conditions: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Dec 2014 (estimated)
Results: Posted 8 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Standard of care + supplementary education	Experimental	Behavioral: Standard of care + supplementary educationSubjects will receive supplementary patient educational material in addition to standard-of-care instructions.
Standard of care	Experimental	Behavioral: Standard of careSubjects will receive standard-of-care instructions only.
Standard of care + additional visits	Experimental	Behavioral: Standard of care + additional visitsSubjects will receive standard-of-care instructions, and two additional clinical visits.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or female subjects age of 12 years or older,
With facial acne vulgaris that can be managed in primary care

Key exclusion criteria (2 listed)

Female subjects who are pregnant, nursing or planning a pregnancy during the study,
Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

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
Standard of care + supplementary education	Behavioural	Standard of care + supplementary education
Standard of care + additional visits	Behavioural	Standard of care + additional visits
Standard of care	Behavioural	Standard of care

Primary outcome

Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
Time frame: week 12
To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.

Results and safety

Results posted to the registry on 8 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care + Supplementary Education	33	25
Standard of Care	33	32
Standard of Care + Additional Visits	31	25

Primary outcome: Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)

Time frame: week 12. Mean (Standard Deviation). Unit: percentage of adherence

Measure	Standard of Care + Supplementary Education n = 20	Standard of Care n = 28	Standard of Care + Additional Visits n = 23
Value	63.1 (30.2)	56.5 (24.8)	48.2 (33.9)

Standard of Care + Supplementary Education vs Standard of Care: p = 0.3165, Cochran-Mantel-Haenszel
Standard of Care + Supplementary Education vs Standard of Care + Additional Visits: p = 0.0206, Cochran-Mantel-Haenszel

Population analysed: Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care + Supplementary Education	0 of 33 (0%)	7 of 33 (21.2%)	Not reported
Standard of Care	0 of 33 (0%)	6 of 33 (18.2%)	Not reported
Standard of Care + Additional Visits	0 of 31 (0%)	15 of 31 (48.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29027127Myhill T, Coulson W, Nixon P, Royal S, McCormack T, Kerrouche N. Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study. Dermatol Ther (Heidelb). 2017 Dec;7(4):515-524. doi: 10.1007/s13555-017-0203-4. Epub 2017 Oct 12.

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RecruitingPhase 4
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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.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Acne, run by Galderma R&D at 10 sites in United Kingdom.

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 2 inclusion and 2 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Sep 2016). 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?

Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02307266, which also lists 1 linked publication.

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 18 Feb 2021.