Compliance with drug treatments and adjuvant barrier repair therapies are key factors for clinical improvement in mild to moderate acne

ISRCTN	ISRCTN14257026
DOI	https://doi.org/10.1186/ISRCTN14257026
Protocol serial number	ACTUO/01/2012
Sponsor	Isdin SA
Funder	Isdin SA, Barcelona (Spain)

Submission date: 08/06/2015
Registration date: 16/07/2015
Last edited: 14/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Massimo Milani
Scientific

Viale Abruzzi 3
Milan
20123
Italy

ORCID ID	0000-0001-7559-1202
Phone	003902949256
Email	masmilan2000@yahoo.it

Study information

Primary study design	Observational
Study design	Observational epidemiological non-interventional prospective 3-month, cohort trial
Secondary study design	Cohort study
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
Study objectives	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(s)	CEIC (Centro Medico Teknon Hospital Quirón Teknon, del Grupo Hospitalario Quirón Barcelona Spain). October 2011, ref: ACTUO/ISDIN/01
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Evaluation of the impact of adherence and compliance to the treatments on the clinical outcome in patients with mild to moderate acne.
Key secondary outcome measure(s)	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.
Completion date	01/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Key inclusion criteria	Mild to moderate acne necessitating topical treatments with retinoid or antibiotics
Key exclusion criteria	Severe acne
Date of first enrolment	01/10/2011
Date of final enrolment	01/10/2012

Locations

Countries of recruitment

Spain

Study participating centres

University Hospital La Paz (Hospital Universitario La Paz)

Madrid
28046
Spain

Hospital Quirón Teknon

Barcelona
08022
Spain

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/09/2015		Yes	No