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 |
| Secondary identifying numbers | ACTUO/01/2012 |
- 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
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
Scientific
Viale Abruzzi 3
Milan
20123
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | 003902949256 |
| masmilan2000@yahoo.it |
Study information
| Study design | Observational epidemiological non-interventional prospective 3-month, cohort trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2011 |
| Completion date | 01/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
28046
Spain
08022
Spain
Sponsor information
Industry
Viale Abruzzi 3
Milan
20123
Italy
| Phone | 003902949678 |
|---|---|
| massimo.milani@isdin.com | |
"ROR" |
https://ror.org/04dg86p75 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/07/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submitted to BMC Dermatology |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/09/2015 | Yes | No |
