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A study to assess the effects and safety of Sofinox Cream (Equivalent to Fusidic Acid 2.0% w/w) and Nicotinamide 3% w/w in volunteers with mild to moderate acne for 8 weeks

A single arm, open label controlled 8 weeks assessment study of the efficacy and safety of topical Sofinox cream (Sodium Fusidate IP equivalent to Fusidic Acid IP 2.0 % w/w) and Nicotinamide 3% w/w cream in volunteers with mild to moderate acne vulgaris

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004103
Enrollment
30
Registered
2013-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Mild to Moderate Acne Vulgaris

Interventions

Intervention1: Sofinox Cream and Nicotinamide Cream: Sodium Fusidate IP equivalent to Fusidic Acid IP 2.0% w/w and Nicotinamide 3% w/w Intervention2: Sofinox cream and Nicotinamide cream: Sofinox crea

Sponsors

Apex Laboratories Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male volunteers, aged 18-40 years Skin phototype III-V (Fitzpatrick) Subjects with mild to moderate facial acne vulgaris Able to give written informed consent and to comply with the requirements of the study

Exclusion criteria

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 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

Design outcomes

Primary

MeasureTime frame
- Count of cutaneous inflammatory acne lesions - Average inflammatory lesion sizeTimepoint: Days 0 (day of inclusion), 14, 28, 42 and 56—

Secondary

MeasureTime frame
- Self-evaluation questionnaire by the subjects at D0, D28 and D56 - Investigatorâ??s assessment of acne severity based on Leeds acne grading scale (Photographic scale) - Recurrence of target inflammatory acne lesions post subsidence - Skin conductivity with Corneometer® on days 0, 14, 28, 42 and 56 - Safety assessmentTimepoint: - Self-evaluation questionnaire by the subjects at D0, D28 and D56 - Investigatorâ??s assessment of acne severity based on Leeds acne grading scale (Photographic scale) - Recurrence of target inflammatory acne lesions post subsidence - Skin conductivity with Corneometer® on days 0, 14, 28, 42 and 56 - Safety assessment at days 0, 14, 28, 42 and 56—

Countries

India

Contacts

Public ContactDr Aalok Makker

CIDP Biotech India Pvt. Ltd

rnangia@cidp-cro.com01140793385

Outcome results

None listed

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