Acne
Conditions
Brief 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 receiving once-daily EpiduoTM gel treatment in primary care clinics.
Interventions
BEHAVIORALStandard of care + supplementary education
BEHAVIORALStandard of care + additional visits
BEHAVIORALStandard of care
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects age of 12 years or older, 2. With facial acne vulgaris that can be managed in primary care
Exclusion criteria
1. Female subjects who are pregnant, nursing or planning a pregnancy during the study, 2. Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care + Supplementary Education Subjects received supplementary patient educational material in addition to standard-of-care instructions. | 33 |
| Standard of Care Subjects received standard-of-care instructions only. | 33 |
| Standard of Care + Additional Visits Subjects received standard-of-care instructions, and two additional clinical visits. | 31 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 5 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care + Supplementary Education | Standard of Care | Standard of Care + Additional Visits | Total |
|---|---|---|---|---|
| Acne History Between 1 and 5 years | 11 participants | 12 participants | 17 participants | 40 participants |
| Acne History Less than 1 year | 12 participants | 9 participants | 7 participants | 28 participants |
| Acne History More than 5 years | 10 participants | 12 participants | 7 participants | 29 participants |
| Age, Continuous | 24.1 years STANDARD_DEVIATION 9.6 | 21.0 years STANDARD_DEVIATION 7.9 | 22.5 years STANDARD_DEVIATION 11.1 | 22.5 years STANDARD_DEVIATION 9.6 |
| Investigator Global Assessment of Acne Almost clear | 8 participants | 1 participants | 3 participants | 12 participants |
| Investigator Global Assessment of Acne Mild | 17 participants | 22 participants | 20 participants | 59 participants |
| Investigator Global Assessment of Acne Moderate | 8 participants | 10 participants | 8 participants | 26 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 26 Participants | 27 Participants | 82 Participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 19 Participants | 67 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 12 Participants | 30 Participants |
| Skin Phototype I | 2 participants | 3 participants | 2 participants | 7 participants |
| Skin Phototype II | 11 participants | 9 participants | 11 participants | 31 participants |
| Skin Phototype III | 14 participants | 13 participants | 12 participants | 39 participants |
| Skin Phototype IV | 5 participants | 6 participants | 4 participants | 15 participants |
| Skin Phototype V | 1 participants | 2 participants | 2 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 33 | 6 / 33 | 15 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 31 |
Outcome results
Primary
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.
Time frame: week 12
Population: Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care + Supplementary Education | Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | 63.1 percentage of adherence | Standard Deviation 30.2 |
| Standard of Care | Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | 56.5 percentage of adherence | Standard Deviation 24.8 |
| Standard of Care + Additional Visits | Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | 48.2 percentage of adherence | Standard Deviation 33.9 |
p-value: 0.0206Cochran-Mantel-Haenszel
p-value: 0.3165Cochran-Mantel-Haenszel