A study to assess the effects and safety of Sofinox cream (Sodium Fusidate IP equivalent to Fusidic Acid IP 2.0% w/w) and Adapalene 0.1% w/w cream in volunteers with mild to moderate acne for 12 weeks

Not Applicable

Completed

Conditions: Health Condition 1: null- Mild to moderate acne vulgaris

Registration Number: CTRI/2013/09/003989

Lead Sponsor: Apex Laboratories Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

Skin phototype III-V (Fitzpatrick)

- Acne prone subjects showing the presence of mild to moderate facial acne vulgaris (Grade 2-7 on Leeds Acne Grading scale), presenting at least 15

inflammatory lesions and at least 25 non-inflammatory lesions on the face

- Female participants with child bearing potential must have a negative urine pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.

Exclusion Criteria

- Patients with any nodulo-cystic lesions at baseline

- Secondary acne and severe acne (acne fulminans, acne conglobata)

- Patients with acne excoriata or having psychological disturbances

Known hypersensitivity to the study drug or constituents

- Any topical or systemic treatment that could interfere with the study treatments/assessments (antibiotics, corticosteroids, retinoids, antiinflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study

- Any surgical treatment on the test areas

- Use of hormonal contraceptives solely for the treatment of acne

- Use of prohibited medications prior to the start and unwillingness to refrain from the use during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Counting of cutaneous inflammatory acne lesions <br/ ><br>- Average inflammatory lesion sizeTimepoint: - Counting of cutaneous inflammatory acne lesions on day 1, 15, 29, 43, 57, 71, 85, 106 <br/ ><br>- Average inflammatory lesion size on day 1, 15, 29, 43, 57, 71, 85, 106

Secondary Outcome Measures

Name	Time	Method
- Self-evaluation questionnaire by the subjects <br/ ><br>- Investigators assessment of improvement in acne on the basis of Leeds acne grading scale (Photographic scale) <br/ ><br>- Recurrence of target inflammatory acne lesions post subsidence <br/ ><br>- Skin conductivity with CorneometerÂ®Timepoint: - Self-evaluation questionnaire by the subjects at D1, D43 and D85 <br/ ><br>- Investigators assessment of improvement in acne on the basis of Leeds acne grading scale (Photographic scale) on days 1, 15, 29, 43 57, 71 and 85 <br/ ><br>- Recurrence of target inflammatory acne lesions post subsidence on days 29, 43 57, 71 and 85 <br/ ><br>- Skin conductivity with CorneometerÂ® on days 1, 15, 29, 43 57, 71 and 85