MedPath

Safety and efficacy assessment of Synskin Acnes 2 cream” and Acnes 3 cream” for treatment of acne

Phase 2
Conditions
L70.0
Acne vulgaris.
Acne vulgaris
Registration Number
IRCT20190210042676N14
Lead Sponsor
Iran Avandfar Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
20
Inclusion Criteria

Male or female aged 16-40 years
Mild to moderate inflammatory or non-inflammatory acne lesions (grade 1 to 3 according to the table) on face

Exclusion Criteria

People with allergies to formulation ingredients
Nodular or cystic lesions that represent a severe type of acne vulgaris

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluate the improvement of acne severity index by a physician. Timepoint: Before intervention, 2, 6 and 10 weeks after the start of use. Method of measurement: 0=normal skin, 2=skin is almost clear, 3=some non-inflammatory lesions are present, 4=non-inflammatory lesions are predominant, with multiple inflammatory lesions. 5=highly inflammatory lesions predominate.
Secondary Outcome Measures
NameTimeMethod
Trans Epidermal Water Loss. Timepoint: Before intervention, 2, 6 and 10 weeks after the start of use. Method of measurement: Tewameter.;Skin sebum. Timepoint: Before intervention, 2, 6 and 10 weeks after the start of use. Method of measurement: Sebumeter.
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