Health Condition 1: null- Mild to Moderate Acne Vulgaris
Conditions
Interventions
Intervention1: SOFINOX-RD cream: Sodium Fusidate IP equivalent to fusidic acid IP 0.25 % w/w
Route- Topical
Dose & Frequency- 1 FTU (finger tip unit, 0.5 g) twice a day for 84 days
Control Interventi
Sponsors
Apex Laboratories Private Limited
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?· Counting of cutaneous inflammatory acne lesions on days 1, 15, 29, 43, 57, 71, 85 ï?· Average inflammatory lesion size on days 1, 15, 29, 43, 57, 71, 85Timepoint: ï?· Counting of cutaneous inflammatory acne lesions on days 1, 15, 29, 43, 57, 71, 85 ï?· Average inflammatory lesion size on days 1, 15, 29, 43, 57, 71, 85 ï?· Follow up at 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?· Investigator Global assessment Severity score ï?· Recurrence of target inflammatory acne lesionsTimepoint: Days 1, 15, 29, 43, 57, 71, 85 | — |
Countries
India
Contacts
Public ContactRashi Nangia
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed