A STUDY TO COMPARE THE EFFECTS AND SAFETY OF SODIUM FUSIDATE CREAM (EQUIVALENT TO FUSIDIC ACID 2.0 %) WITH SODIUM FUSIDATE CREAM (EQUIVALENT TO FUSIDIC ACID 0.25 %) 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/2012/08/002928
• Lead Sponsor: Apex Laboratories Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Skin phototype III-V (Fitzpatrick)

- Mild to moderate facial acne vulgaris [Grade 2, Grade 3 on the Investigator Global Assessment (IGA) scale]

- A minimum of 20 but not more than 50 inflammatory lesions (papules and pustules)

- A minimum of 25 but not more than 100 non-inflammatory lesions (open and closed comedones)

- Able to give written informed consent and to comply with the requirements of the study

- No treatment for acne in the past 1 month

- All skin types (greasy, normal) except sensitive skin

- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study

- Female participants must have a negative 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); Inflammatory acne lesion count > 50

- Patients with acne excoriata or having psychological disturbances

- Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea

- Known dermal sensitivity to light (photosensitivity)

- 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 (laser peel, dermabrasion, etc.)

- Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use, etc.) for aesthetic or therapeutic reason the month before the study start or during the study

- Any significant medical condition that would interfere in the participation in the trial.

- Participation in a clinical trial up to 1 month prior to inclusion.

- Pregnant women (as confirmed by UPT) and lactating women.

- Patients with severe eczema

- Use of hormonal contraceptives, unless the subject was on stable dose i.e at

least 6 months of treatment before enrollment

- 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

- Specified washout period(s) upto Baseline

Topical:

Topical antibiotics and other topical antibacterial drugs (4 weeks),

Facial anti-inflammatory agents and corticosteroids (4 weeks)

Retinoids, including retinol (4 weeks)

Systemic medications :

Corticosteroids and intra-muscular injections (4 weeks), antibiotics (4 weeks)

Other systemic acne treatments (4 weeks), and systemic retinoids (6 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified