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MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE THERAPY WITH THE COMBINATION OF BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% W/W FOR THE TOPICAL TREATMENT OF ACNE VULGARIS

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE THERAPY WITH THE COMBINATION OF BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% W/W FOR THE TOPICAL TREATMENT OF ACNE VULGARIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016240-40-GR
Enrollment
Unknown
Registered
2010-04-16
Start date
2010-06-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

ACNE VULGARIS

Interventions

Trade Name: ERYBENZ Product Name: BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% Product Code: BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD Pharmaceutical Form: Gel INN or Proposed INN: BENZOYL PER

Sponsors

VERISFIELD (UK) LTD, GREEK BRANCH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - PATIENTS WITH MILD TO MODERATE ACNE VULGARIS - MALE AND FEMALE PATIENTS AGED 12-35 YEARS - MALES AND FEMALES WHO ARE CONSIDERED HEALTHY - FEMALE PATIENTS WHO DO NOT SHOW ANY SIGNS OF HYPERANDROG?NISM Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - PATIENTS WHO HAVE PARTICIPATED OR CURRENTLY PARTICIPATING TO ANOTHER STUDY - PATIENTS ON TOPICAL OR SYSTEMIC TREATMENT FOR ACNE VULGARIS - PATIENTS WHO RECEIVE DRUGS THAT MIGHT INFLUENCE THE FINDINGS OF THE STUDY - PATIENTS WITH CARDIOVASCULAR, NEOPLASMATIC, HAEMATOLOGICAL, HEPATIC, NEUROLOGICAL, RENAL, ENDOCRINE AND GASTROENTEROLOGICAL DISEASE - PATIENTS WITH A DERMATOLOGICAL LESION IN THE AREA (OR IN CLOSE PROXIMITY e.g. 3cm) TO BE TREATED - PREGNANT OR LACTATING PATIENTS - FEMALE PATIENTS IN REPRODUCTIVE AGE WHO DO NOT USE ADEQUATE CONTRACEPTION

Design outcomes

Primary

MeasureTime frame
Main Objective: THE MAIN OBJECTIVE OF THE TRIAL IS TO COMPARE THE EFFICACY OF THE TEST TOPICAL FORMULATION BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% TO THE REFERENCE BENZADERMINE/LABORATOIRES PHARMACETIQUES TRENKER, GEL, (5+3)% AND TO EVALUATE THE THERAPEUTIC EQUIVALENCE BETWEEN THE TWO PRODUCTS IN PATIENTS WITH A CLINICAL DIAGNOSIS OF MILD TO MODERATE ACNE VULGARIS;Secondary Objective: EVALUATION OF THE SAFETY;Primary end point(s): FINDINGS THAT DEMONSTRATE THE THERAPEUTIC EQUIVALENCE BETWEEN THE TEST (BENZOYL-PEROXIDE-ERYTHROMYCIN/VERISFIELD) AND THE REFERENCE PRODUCT (BENZADERMINE/LABORATOIRES PHARMACETIQUES TRENKER).—

Countries

Greece

Outcome results

None listed

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