Acne | Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne
Acne research study
What is the primary objective of this study?
Skin cleanser for daily used is essential and one of the most common questions asked by acne patients. There are studies reported beneficial effects of cleansers in acne treatment. Extracts of plants as active ingredients in skin cleansers are increasingly popular worldwide. Roselle is a common tropical shrub. Usually, the calyces of the plant have been used to make beverages but it also used in Thai traditional medicine for several purposes including as antiseptic and astringent. The extract of roselle showed antioxidant and keratolytic effects from previous studies which fit to the pathogenesis of acne. The aims of the study is to determine the safety and efficacy of skin cleanser contained roselle extract in acne.
Who is eligible to participate?
Inclusion Criteria: - age 12-45 yrs,both sex - clinical diagnosis of mild to moderately severe acne vulgaris(grade 1-3) - have at least 10 facial acne lesions - not changing any acne treatment during study period - able to follow up according to protocol - Written informed consent Exclusion Criteria: - pregnant or breast feeding - severe acne(grade4 or nodulocystic acne) - treated with isotretinoin orally during the last 3 months - have other systemic disease or illness - have allergic history to Roselle
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:skin cleanser contained Hibiscus sabdariffa extractface washing 2-3 times/day
Other:marketed skin cleanserface washing 2-3 times/day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1skin cleanser contained Hibiscus sabdariffa
2marketed skin cleanser
Start Date: April 2008
Completed Date: September 2008
Phase: Phase 2
Primary Outcome: 1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading
Secondary Outcome: 1. Safety evaluation: "a." Skin properties by visual and tactile features., "b." Biophysical parameters of skin. 2.Efficacy evaluation: Patient assessments.
Study sponsors, principal investigator, and references
Principal Investigator: Mali - Achariyakul, MD.
Lead Sponsor: Thammasat University
Collaborator: National Research Council of Thailand