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Efficacy of a spray formulation in acne of the chest and back

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38383374
Enrollment
75
Registered
2016-05-05
Start date
2015-02-02
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Truncal acne vulgaris Skin and Connective Tissue Diseases Truncal acne vulgaris

Interventions

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

Sponsors

Difa Cooper
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Italy

Contacts

Public ContactMassimo Milani

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026