Condition category
Skin and Connective Tissue Diseases
Date applied
25/01/2018
Date assigned
01/02/2018
Last edited
30/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acne vulgaris is a chronic (long-term) inflammatory skin disease, and is commonly treated with topical or systemic drugs according to the severity of the condition. Retinoids and antibiotic compounds are considered a cornerstone approach in this condition. However, adherence to the treatment and the issue of bacterial resistance undermine the effectiveness in the long term. Photodynamic therapy (PDT) is a treatment that involves the use of light-sensitive medication and a light source to destroy abnormal cells. PDT with aminolevulinic acid (ALA) 20% has been shown to be effective in the treatment of inflammatory acne. Skin tolerability (discomfort) however could be a limiting factor for a widespread use of this approach. A new formulation of ALA 5% in thermosetting gel has recently become available. This formulation allows more convenient application without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments. The aim of this study is to assess the effectiveness of red light PDT using ALA 5% in thermosetting gel in the treatment of mild to moderate acne vulgaris.

Who can participate?
Patients with mild to moderate acne vulgaris with unsatisfactory previous treatments for acne (i.e., topical retinoid, antibiotics)

What does the study involve?
ALA 5% gel is gently applied on the face and rubbed until completely absorbed. After 120 minutes of “incubation” in a dark room, a PDT session is performed (15 minutes under a red light lamp). A second and third PDT session are performed two weeks apart. Acne severity is assessed at the start of the study, after the third PDT session and at a follow-up visit 6 months after the last PDT session.

What are the possible benefits and risks of participating?
Participants may benefit from an effective and well tolerated treatment of their acne without the drawback of poor skin tolerability (retinoids) or progressive lack of effectiveness due to bacterial resistance.

Where is the study run from?
1. Dermatology Clinic University Tor Vergata Rome (Italy)
2. Dermatology Outpatient Service Dr S. Serini (Italy)

When is the study starting and how long is it expected to run for?
February 2017 to January 2018

Who is funding the study?
Cantabria Labs Difa Cooper (Italy)

Who is the main contact?
Dr Massimo Milani
massimomilani1959@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Massimo Milani

ORCID ID

Contact details

Via Nota
Milan
20123
Italy
+39 (0)29654231
massimomilani1959@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ALAFAST1AC

Study information

Scientific title

The efficacy and safety of "low-dose" 5-aminolevulinic acid (ALA) thermosetting gel photodynamic therapy in the treatment of mild to moderate acne vulgaris

Acronym

Study hypothesis

To evaluate efficacy and tolerability of red light photodynamic therapy (PDT) using a novel 5-aminolevulinic acid in thermosetting gel in the treatment of mild to moderate acne vulgaris.

Ethics approval

University of Tor Vergata, Rome, Ethical Committee, 22/02/2017

Study design

Multicenter prospective assessor-blinded non-comparative trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Mild to moderate acne vulgaris

Intervention

ALA 5% gel single application was gently applied 2.5 g on the face and rubbed until complete absorption. After 120 minutes of “incubation” in a dark room, a PDT session (15 minutes under red light lamp with a peak of 630 nm) was performed. A second and a third PDT session were performed two weeks apart. The follow-up visit was performed 6 months after the last PDT session.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Acne severity, assessed using the Global Acne Grading System (GAGS) score according to Doshi (Int J Dermatol 1997 36:416) at baseline, after the third PDT session and at the follow-up visit. A GAG score of 1-18 is considered mild; 19-30, moderate; 31-38, severe; and >39, very severe.

Secondary outcome measures

Patient-reported local tolerability score (a 4-item grading scale: 0: no skin discomfort; 3: severe skin discomfort) after each PDT session

Overall trial start date

01/02/2017

Overall trial end date

15/01/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Mild to moderate acne vulgaris

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35

Participant exclusion criteria

1. Severe acne
2. Skin phototype I
3. Positive history of skin tumor
4. Photodermatosis

Recruitment start date

01/05/2017

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Italy

Trial participating centre

Dermatology Clinic University Tor Vergata Rome
Viale Oxford 1
Rome
00100
Italy

Trial participating centre

Dermatology Outpatient Service Dr S. Serini
Viale Sondrio 2
Milan
20100
Italy

Sponsor information

Organisation

Cantabria Labs Difa Cooper

Sponsor details

Via Milano 160
Caronno Pertusella
21042
Italy
+39 (0)29659031
massimo.milani@difacooper.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Cantabria Labs Difa Cooper

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan is to submit the manuscript to a peer-reviewed international journal.

IPD sharing statement
Data regarding outcomes, demographic variables and written informed content are stored in an internal repository and are not freely available.

Intention to publish date

01/10/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes