Mild to moderate facial acne
Conditions
Interventions
Study setting: MAS Linea Aqua, a garment factory with over 3000 employees. Details about the study will be communicated by using the leaflet prepared in Sinhala, Tamil and English. Volunteer participa
Sponsors
Link Natural Products (Pvt) Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-nursing females, above 25 years, with mild to moderate facial acne. 2. Presenting minimum 5 acne lesions (whiteheads, blackheads, papules, pustules). 3. Investigator Global Assessment Scale for acne severity (IGA) at baseline should be below or equal 3 4. Participants who are not on any medical treatment for acne.
Exclusion criteria
Exclusion criteria: 1. Use of any topical and systemic acne medical treatments or any antibiotics, if any, were not discontinued at least 4 weeks before entry into the study. 2. Participants who have received topical or oral isotretinoin or retinoid treatment in the 6 months prior to study inclusion. 3. Known allergy to ingredients of the product. 4. Use of hormonal therapy including oral contraceptive pills within 3 months prior to study commencement. 5. Any significant medical conditions that could confound the interpretation of the study. 6. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to commencement of the study. 7. Have open infected acne lesions. 8. On any long-term medicines, including nutritional, Ayurveda/ herbal supplements. 9. Participants who have a history of Asthma or catarrh, diabetes or any other chronic or acute illness. 10. Those who are diagnosed with or showing major symptoms of a systemic disease-causing acne, such as polycystic ovarian syndrome, Cushing’s syndrome will excluded from the study. 11. Other facial skin or generalized dermatological disorders: rosacea, atopic dermatitis, perioral dermatitis, psoriasis etc.. 12. Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the total acne lesion counts (Change in sum of Comedones + Papules + Pustules ) [At baseline, 1st month, 2nd month, 3rd month] Change from baseline in the non-inflammatory acne lesion counts (Change in sum of open and closed comedones) [At baseline, 1st month, 2nd month, 3rd month] Change from baseline in the inflammatory acne lesion counts (Change in sum of papules and pustules) [ At baseline, 1st month, 2nd month, 3rd month] Change from baseline in participant’s efficacy measured by Investigator Global Assessment Score [At baseline, 1st month, 2nd month, 3rd month] Change from baseline in participant’s reported quality of life score using the validated questionnaire [At baseline, 1st month, 2nd month, 3rd month] Change from baseline in sebum production measured by Sebumeter (Courage & Khazaka, Cologne, Germany). [At baseline, 1st month, 2nd month, 3rd month] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in results of laboratory biochemical tests, Liver profile- AST, ALT, ALP, GGT, Serum albumin, total bilirubin, total protein) , Renal profile (UFR, Serum creatinine, GFR) , Full blood count in participants [At baseline, 6th week, 12th week] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Jennifer Perera
Consultant Clinical Trials
Outcome results
None listed