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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 17, 2008 | ||||||||
| Last Updated Date | June 17, 2008 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
1. Safety evaluation: "a." Skin properties by visual and tactile features., "b." Biophysical parameters of skin. 2.Efficacy evaluation: Patient assessments. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne | ||||||||
| Official Title ICMJE | Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Acne is one of the most common skin problems in teenagers and adolescents. Keys pathogenesis of the disease are 1.abnormal hypercornification of pilosebaceous duct,2.excess sebum production, 3.inflammation, 4.the present of Propionibacterium acnes. Treatments often include combination of topical and oral medications according to degree of acne severities. Acne medications can lead to drying and irritation of skin. Proper skin cleansing is important and can improve tolerability and efficacy of acne treatment. Traditional medicine with longstanding used of herbal ingredients for skin problems and beauty is increasing more popular. Hibiscus sabdariffa L.(Roselle) is used as food, drink and topical formulation for skin infection in Thai traditional medicine. The extract from calyces contained polyphenolic compounds and anthocyanins that showed antioxidant and keratolytic activities. There for skin cleanser with Roselle extract might be benefit to acne by loosen comedone, reduce Propionibacterium acne and prevent keratinocyte injury. The purposes of this study is to evaluate skin cleanser contained Roselle extract in two aspects ; 1. safety for irritation and allergic effects, 2. efficacy in acne as cleanser alone and as supportive care with others acne therapies. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Acne | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | September 2008 | ||||||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00701480 | ||||||||
| Responsible Party | Mali Achariyakul/Dr., Thammasat University | ||||||||
| Study ID Numbers ICMJE | MTU-E-1-002/51 | ||||||||
| Study Sponsor ICMJE | Thammasat University | ||||||||
| Collaborators ICMJE | National Research Council of Thailand | ||||||||
| Investigators ICMJE |
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| Information Provided By | Thammasat University | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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