Condition category
Skin and Connective Tissue Diseases
Date applied
02/05/2016
Date assigned
05/05/2016
Last edited
05/05/2016
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 which causes spots to develop on the skin, usually the face, chest and back. Even cases of mild acne can be distressing, as not only can it make people feel self-conscious, it can be painful. The majority of treatments for acne involve applying medications directly to the skin (topical medication), such as creams, gels and lotions. These products can contain a wide range of different chemicals, including retinoids (vitamin A by-products that help to remove dead skin cells from the surface of skin), antibiotics (which kill bacteria on the skin that can cause infections leading to spots) and keratolytic substances (peeling agents). When acne affects the chest or back, it can be difficult to apply topical medications in the form of creams, gels and lotions as these areas can be hard to reach. Sprays are therefore considered to be a far more convenient treatment option, as they are able to reach where the sufferer otherwise would not be able to. The aim of this study is to compare three different acne spray formulations, in order to find out if a spray containing retanoids, antibiotics and keratolytic substances is more effective than sprays containing keratolytic substances alone.

Who can participate?
Adults with mild to moderate acne on the back and chest.

What does the study involve?
Participants are randomly allocated to receive one of three products. The first product is a new spray which contains retinol and hydroxypinacolone retinoate (vitamin A by-products), an antibacterial product, salicylic acid (a plant hormone commonly used to treat common skin and foot warts) and, vitamin E. The second and third products both contain different keratolytic substances (peeling agents that help to soften and shed the outer layer of skin). All products are applied twice a day for six weeks using four to five sprays on the affected area of skin. At the start of the study and after six weeks, participants in all groups have their acne examined to find out if there has been any improvement. Participant are also interviewed after six weeks in order to find out how their skin has reacted to the spray that they used.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their acne as a result of using the treatment sprays. There are no notable risks involved with taking part in the study, although there is a chance than the product used may not be effective or cause skin irritation.

Where is the study run from?
Clinica di Dermatologia Seconda Università Napoli (Italy)

When is the study starting and how long is it expected to run for?
December 2014 to February 2016

Who is funding the study?
Difa Cooper (Italy)

Who is the main contact?
Dr Massimo Milani

Trial website

Contact information

Type

Public

Primary contact

Dr Massimo Milani

ORCID ID

Contact details

Difa Cooper
Via Milano 160
Caronno Pertusella
21042
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR2015/1

Study information

Scientific title

Efficacy and local tolerability of different spray products in the treatment of mild to moderate acne of the back and chest: A controlled, three-arm, assessor-blinded prospective trial

Acronym

Study hypothesis

The aim of this study is to evaluate whether a spray containing retinoids, antibacterial, emollient and keratolytic substances is more effective than other two products containing containing keratolytic and emollient compounds only at treating moderate acne of the chest and back.

Ethics approval

Policlinico Federico II Naples, 10/01/2015

Study design

Prospective observer-masked three arm randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No specific participant information sheet available, please use the contact details below to request a further information.

Condition

Truncal acne vulgaris

Intervention

Participants are randomly allocated in a 1:1:1 ratio to receive one of three products.

Product 1: A new spray formulation containing 0.15% of two vitamin A derivatives (retinol and hydroxypinacolone retinoate) carried in a patented glycospheres system (RetinSphere®), an antimicrobial peptide (BIOPEP.15), salicylic acid and, vitamin E (BR).
Product 2: A spray formulation containing triethyl citrate and ethyl linoleate, GT-peptide-10, salycilic acid 0,5% and Zinc Lattate.
Product 3: A spray formulation containing betaine, glycine and salicylic acid 2% (SP).

All products are to be applied twice daily (one application in the morning and one application in the evening) for 6 consecutive weeks. The total amount of product is 4/5 puffs per application (a total of 1.2/1.5 ml), in order to cover chest and back areas.

All participants are followed up at six weeks.

Intervention type

Drug

Phase

Phase III/IV

Drug names

1. Bioretix ultra spray
2. Aknicare CB
3. Salipil spray

Primary outcome measures

Clinical evolution of acne lesions is measured using the Global Acne Grading System (GAGS) at baseline and 6 weeks.

Secondary outcome measures

Skin tolerability is measured by evaluating skin irritation (erythema and burning) and skin xerosis using a quantitative score from 0(no symptom) to 3(relevant symptom) at 6 weeks.

Overall trial start date

01/12/2014

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Presence of mild to moderate acne involving back and chest regions (truncal acne)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75 (a total of 25 subjects per treatments arm)

Participant exclusion criteria

1. Severe forms of acne requiring systemic treatments
2. Other severe skin conditions
3. Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
4. Use of oral antibiotics within 30 days
5. Use of systemic corticosteroids within 4 weeks
6. Body Mass Index >30

Recruitment start date

02/02/2015

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Clinica di Dermatologia Seconda Università Napoli
Via Pansini
Naples
0182
Italy

Sponsor information

Organisation

Difa Cooper

Sponsor details

Via Milano 160
Caronno Pertusella
21042
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Difa Cooper

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/09/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes