Condition category
Skin and Connective Tissue Diseases
Date applied
08/06/2015
Date assigned
16/07/2015
Last edited
14/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26361978

Publication citations

Additional files

Editorial Notes