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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN38383374 |
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Date of registration:
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05/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of a spray formulation in acne of the chest and back
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Scientific title:
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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 |
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Date of first enrolment:
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02/02/2015 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN38383374 |
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Study type:
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Interventional |
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Study design:
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Prospective observer-masked three arm randomised parallel trial (Treatment)
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Phase:
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Phase III/IV
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Countries of recruitment
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Italy
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Contacts
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Name:
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Massimo
Milani |
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Address:
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Difa Cooper
Via Milano 160
21042
Caronno Pertusella
Italy |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 years and over
2. Presence of mild to moderate acne involving back and chest regions (truncal acne)
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Truncal acne vulgaris
Skin and Connective Tissue Diseases
Truncal acne vulgaris
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Intervention(s)
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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.
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Primary Outcome(s)
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Clinical evolution of acne lesions is measured using the Global Acne Grading System (GAGS) at baseline and 6 weeks.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Difa Cooper
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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