Plain English Summary
Background and study aims
Acne is a common skin condition that causes spots to develop on the skin, most noticeably on the face, but also other areas such as the back and the chest. The condition can be mild and result in a few surface blackheads and whiteheads, or severe with deep, inflamed and pus-filled pustules and cysts. Treatment varies from special creams, lotions or gels (topical treatments available from pharmacies) to stronger creams and antibiotics (available only on prescription). Poor adherence to the treatment is a common reason for failure to treat acne successfully. This includes not getting the medication recommended, not using the medication, stopping taking the medication early or not understanding how to apply the medication. Here, we want to test in a real- life setting conditions impact of adherence to physician’s instructions, recommendations and compliance to the treatments on clinical outcome in patients with mild to moderate acne.
Who can participate?
Adults that have mild to moderate acne needing to be treated with topical treatments with retinoid or antibiotics.
What does the study involve?
Participants are asked to comply with physician instruction and recommendations for treating acne. Prescribed treatments include specific anti acne drugs, facial cleansing products, and emollient and hydrating topical products. Each participant takes part in the study for 3 months.
What are the possible benefits and risks of participating?
Potential benefits include improvement of acne.
Where is the study run from?
University Hospital La Paz and Hospital Quirón Teknon (Spain)
When is the study starting and how long is it expected to run for?
October 2011 to November 2013
Who is funding the study?
Isdin SA, Barcelona (Spain)
Who is the main contact?
Dr Massimo Milani
masmilan2000@yahoo.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Massimo Milani
ORCID ID
http://orcid.org/0000-0001-7559-1202
Contact details
Viale Abruzzi 3
Milan
20123
Italy
003902949256
masmilan2000@yahoo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACTUO/01/2012
Study information
Scientific title
Compliance with drug treatments and adjuvant barrier repair therapies are key factors for clinical improvement in mild to moderate acne: The ACTUO observational prospective multicenter cohort trial in 643 patients
Acronym
Study hypothesis
To evaluate by means of an observational, epidemiological, non-interventional prospective 3-month, cohort trial carried out in 72 Dermatologic Services in Spain (ACTUO Trial) the adherence and compliance to antiacne treatments by means of a validated questionnaire (ECOB) to prescribed treatments on the clinical outcome
Ethics approval
CEIC (Centro Medico Teknon Hospital Quirón Teknon, del Grupo Hospitalario Quirón Barcelona Spain). October 2011, ref: ACTUO/ISDIN/01
Study design
Observational epidemiological non-interventional prospective 3-month, cohort trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mild to moderate acne
Intervention
The study was carried out in more than 600 subjects with mild-to-moderate acne with facial involvement. Prescribed treatments were:
1. Specific anti acne drugs: topical retinoids, topical antiseptics
2. Coadjuvant products: specific facial cleansing products, emollient and hydrating topical products
3. Total study duration per patient was 3 months
Intervention type
Other
Phase
Drug names
Primary outcome measure
Evaluation of the impact of adherence and compliance to the treatments on the clinical outcome in patients with mild to moderate acne.
Secondary outcome measures
Evaluation of the impact of the use of specific adjuvant treatments (facial cleansing, emollient moisturizing and lenitive specific topical products) on adherence level and entity of the clinical outcome obtained.
Acne severity was assessed at each visit with a 5-point score system (from 0 to 4), absolute count of lesions and percentage of patient reaching a ≥50% reduction in lesion numbers.
Adherence and Compliance were evaluated at visit 2 and visit 3 by means of validated 4-item questionnaire (ECOB) with a dichotomous classification: good adherence/compliance (ECOB score 4) and poor adherence/compliance (ECOB score <4). Poor compliance to treatment was defined as a different to expected answer on the ECOB questionnaire.a negative answer to question number 2 or number 3 of ECOB questionnaire.
Overall trial start date
01/10/2011
Overall trial end date
01/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Mild to moderate acne necessitating topical treatments with retinoid or antibiotics
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
Severe acne
Recruitment start date
01/10/2011
Recruitment end date
01/10/2012
Locations
Countries of recruitment
Spain
Trial participating centre
University Hospital La Paz (Hospital Universitario La Paz)
Madrid
28046
Spain
Trial participating centre
Hospital Quirón Teknon
Barcelona
08022
Spain
Sponsor information
Organisation
Isdin SA
Sponsor details
Viale Abruzzi 3
Milan
20123
Italy
003902949678
massimo.milani@isdin.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Isdin SA, Barcelona (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted to BMC Dermatology
Intention to publish date
30/07/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26361978