Plain English Summary
Background and study aims
Acne is a common skin condition that causes spots, oily skin and sometimes skin that's hot or painful to touch, and often develops on the face. The aim of this study is to test the effectiveness and safety of ANW as a medical device for the treatment of facial acne.
Who can participate?
Patients aged over 18 with facial acne
What does the study involve?
Participants are randomly allocated to be treated with either the ANW solution or purified water (placebo/dummy drug). The treatments are sprayed on the face twice daily for 12 weeks. No other skin treatment for acne is allowed, except the ones agreed with the researcher at the start of the study.
Assessments are carried out after 2, 4, 8, 12 and 16 weeks for follow up of effectiveness and safety.
What are the possible benefits and risks of participating?
Results obtained with equivalent devices indicate that ANW may be effective in the treatment of acne. No side effects are expected from the use of this device.
Where is the study run from?
San Raffaele Scientific Institute (Italy)
When is study starting and how long is it expected to run for?
March 2011 to May 2012
Who is funding the study?
Applied Pharma Research (Switzerland)
Who is the main contact?
Prof. Santo Raffaele Mercuri
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of the efficacy of treatment with ANW for facial acne
Acronym
ACNE_ANW
Study hypothesis
The hypothesis is that ANW works better than placebo in the treatment of facial acne (degree 2-3 of IGA scale)
Ethics approval
Il Comitato Ethico Della Fondazione Centro San Raffaele del Monte Tabor Istituto Scientifio Ospedale San Raffaele - Milanom, 09/09/2010
Study design
Double-blind randomized monocentric placebo-controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the sponser details to request a patient information sheet
Condition
Facial acne
Intervention
1. ANW vs placebo
2. Two daily treatments (morning and evening for 12 consecutive weeks
3. Each daily treatment consists in spraying the product on the skin affected by acne (13 times of 100ul each to cover the entire face) and let it dry for at least 2 minutes, then in repeating the operation and let it dry again for at least 2 minutes
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. The present pilot study will assess the efficacy and safety of ANW solution in the treatment of facial acne
2. Both the assessment of the IGA and the number of inflammatory (mainly papules and pustules) and non inflammatory (mainly comedones) lesions will serve as primary end-points for quantifying treatment efficacy, to be assessed at each planned visit, including the first (recruitment) visit
3. Non-inflammatory lesions (open -blackheads- or closed -white heads- comedones), are not expected to be affected by ANW treatment
4. Nevertheless, they will be counted in order to evaluate whether there is any effect on this parameter, either curative or comedogenic
5. The safety of the product will be monitored during the whole study by reporting all the Adverse Events in the CRF, diary
Secondary outcome measures
1. Subjects who will provide specific consent will be photographed by a standardized method, using high-resolution digital photography
2. In any case photos will be taken with a framing and/or post-acquisition elaboration preventing recognition of the photographed subject
3. A nine-score grading of acne severity will be performed by the Investigator according to his/her clinical judgement at each visit starting from scheduled visit 2
4. This assessment will considered modification of the clinical severity in comparison with the previous scheduled visit, in accordance to the following qualitative evaluation (as reported in proper CRF)
5. Each subject is invited to report daily in the diary his/her subjective evaluation regarding the treatment
6. Furthermore, a standardized questionnaire on Quality of Life assessment in subjects affected by facial acne (Acne-QoL) will be appended to the diary for self-administration at two visits, namely at study entry and after the 12-week treatment period (scheduled visit number 5)
7. The 19 questions of Acne-QoL are framed to be specific to site (... because of your facial acne) and time (... in the past week)
8. The measurement of psychosocial impact of disease has, until recently, been a relatively neglected component of the clinical paradigm
9. In acne, increasing recognition that objective clinical measures may be inadequate in assessing the overall impact and effect of this disease has led to the development of disease-specific psychometric instruments
10. The Acne-QoL questionnaire was developed specifically to assess health-related quality of life for clinical trials in acne and has been widely validated in several clinical studies
Overall trial start date
08/03/2011
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Male or female patients with acne
2. Above age 18
3. Able to comply with the study procedures, in the opinion of the investigator, and able to give a voluntary written informed consent for participation in the trial
4. Diagnosis of severity of facial acne either 2 or 3 grade according to the Investigators Global Assessment (IGA) scale
5. The patient can exclude to become pregnant during the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnancy
2. Breastfeeding
3. More than one nodulo-cystic lesion per side of the face
4. Subject with facial acne who used any topical treatment in the last 7 days, and/or systemic antibiotic therapy in the last 30 days and/or systemic retinoid in the last six months
5. Cancer or history of cancer
6. Significant history of hematologic, cardiovascular, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease
7. Reported HIV infection
8. Known or suspected individual hypersensitivity to any component of the product
9. Use of hormonal contraceptives, stilbestrol/ d.e.s., primidone, fluoxetine, phenylpropanolamine, methylphenidate, troglitazone, gemfibrozil, cerivastatin, isotretinoin
Recruitment start date
08/03/2011
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Italy
Trial participating centre
San Raffaele Scientific Institute and San Raffaele University Medical School Vita-Salute
Milano
20132
Italy
Sponsor information
Organisation
Applied Pharma Research (Switzerland)
Sponsor details
via Corti 5
Balerna
CH-6828
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Applied Pharma Research (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list