Condition category
Skin and Connective Tissue Diseases
Date applied
06/07/2011
Date assigned
16/08/2011
Last edited
13/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

Contact information

Type

Scientific

Primary contact

Prof Santo Raffaele Mercuri

ORCID ID

Contact details

Dermatology Unit
San Raffaele Scientific Institute and San Raffaele University Medical School Vita-Salute
via Olgettina
60
Milano
20132
Italy

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 measures

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

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 Investigator’s 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

http://www.apr.ch/site/index.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/04/2017: Plain English summary added. 12/09/2012: Please note that this trial was stopped in September 2012 due to a lack of participants.