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MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE STUDY WITH THE REFERENCE PRODUCTS, FOR ASSESSMENT OF THERAPEUTIC SUPERIORITY OF THE COMBINATION CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)%, (VERSUS THE MONOTHERAPY WITH CLINDAMYCIN OR TRETINOIN) FOR THE TOPICAL TREATMENT OF ACNE

MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE STUDY WITH THE REFERENCE PRODUCTS, FOR ASSESSMENT OF THERAPEUTIC SUPERIORITY OF THE COMBINATION CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)%, (VERSUS THE MONOTHERAPY WITH CLINDAMYCIN OR TRETINOIN) FOR THE TOPICAL TREATMENT OF ACNE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017201-11-GR
Enrollment
Unknown
Registered
2010-04-19
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 (ACNE VULGARIS)

Interventions

Product Name: CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)% Product Code: CLINDAMYCIN-TRETINOIN/VERISFIELD Pharmaceutical Form: Gel INN or Proposed INN: CLINDAMYCIN CAS Number: 24729-96-2 Other

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 - PATIENTS WHO ACCORDING TO THE MEDICAL SUPERVISOR ARE HEALTHY 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 OF GASTROENTEROLOGICAL DISEASE - PATIENTS WITH A DERMATOLOGICAL LESION IN THE AREA (OR IN CLOSE PROXIMITY e.g. 3cm) TO BE TREATED - PREGNANT OF LACTATING PATIENTS - PATIENTS IN REPRODUCTIVE AGE WHO DO NOT USE ADEQUATE CONTRACEPTION

Design outcomes

Primary

MeasureTime frame
Main Objective: MAIN OBJECTIVE OF THE CLINICAL STUDY IS THE ASSESSMENT OF THERAPEUTIC SUPERIORITY OF THE COMBINATION CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)% FOR THE TOPICAL TREATMENT OF ACNE, VERSUS THE MONOTHERAPY WITH CLINDAMYCIN, GEL, 1.0% AND TRETINOIN, GEL, 0.025%, SEPARATELY FOR THE TOPICAL TREATMENT OF ACNE;Secondary Objective: ASSESSMENT OF SAFETY OF THE TOPICAL TREATMENT WITH COMBINATION OF CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)%;Primary end point(s): FINDINGS THAT DEMONSTRATE THE THERAPEUTIC SUPERIORITY OF THE COMBINATION OF CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)% COMPARED TO THE MONOTHERPAPIES WITH DALACIN-C, GEL, 1.0% AND RETIN-A, GEL, 0.025%—

Countries

Greece

Outcome results

None listed

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