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MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF THE THERAPY WITH THE COMBINATION ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)% W/W FOR THE TOPICAL TREATMENT OF MILD TO MODERATE ACNE

MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF THE THERAPY WITH THE COMBINATION ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)% W/W FOR THE TOPICAL TREATMENT OF MILD TO MODERATE ACNE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016241-25-GR
Enrollment
Unknown
Registered
2010-04-19
Start date
2010-06-15
Completion date
Unknown
Last updated
2012-12-17

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

Conditions

MILD TO MODERATE ACNE (ACNE VULGARIS)

Interventions

Product Name: ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)% Product Code: ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD Pharmaceutical Form: Gel INN or Proposed INN: ERYTHROMYCIN CAS Number: 114-07-8

Sponsors

VERISFIELD (UK) LTD, GREEK BRANCH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - PATIENTS WITH MILD TO MODERATE ACNE (ACNE VULGARIS) - MALE AND FEMALE PATIENTS AGED 12-35 YEARS - MALES AND FEMALES WHO ARE CONSIDERED HEALTHY - FEMALE PATIENTS WHO DO NOT MANIFEST ANY SIGNS OF HYPERANDROGENISM 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 IN ANOTHER STUDY - PATIENTS ON TOPICAL OR SYSTEMIC TREATMENT FOR ACNE - PATIENTS WHO RECEIVE DRUGS THAT MIGHT INFLUENCE THE FINDINGS OF THE STUDY - PATIENTS WITH CARDIOVASCULAR, NEOPLASMIC, HAEMATOLOGICAL, HEPATIC, RENAL, NEUROLOGICAL, 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 RECEIVE ADEQUATE CONTRACEPTION

Design outcomes

Primary

MeasureTime frame
Main Objective: COMPARATIVE ASSESSMENT OF THE THERAPEUTIC EQUIVALENCE OF THE TEST PRODUCT ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)% WITH THAT OF THE REFERENCE ISOTREXIN/STIEFEL LABS UK, GEL, (2.0+0.05)% IN PATIENTS WITH MILD TO MODERATE ACNE (ACNE VULGARIS);Secondary Objective: SAFETY ASSESSMENT OF THE TREATMENT WITH ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)%;Primary end point(s): DEMONSTRATE THE THERAPEUTIC EQUIVALENCE BETWEEN THE TEST AND THE REFERENCE PRODUCT—

Countries

Greece

Outcome results

None listed

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