Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne
Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJune 19, 2008
June 1, 2008
3 months
June 17, 2008
June 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading
6 weeks
Secondary Outcomes (1)
1. Safety evaluation: "a." Skin properties by visual and tactile features., "b." Biophysical parameters of skin. 2.Efficacy evaluation: Patient assessments.
6 weeks
Study Arms (2)
1
EXPERIMENTALskin cleanser contained Hibiscus sabdariffa
2
ACTIVE COMPARATORmarketed skin cleanser
Interventions
face washing 2-3 times/day
face washing 2-3 times/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thammasat Universitylead
- National Research Council of Thailandcollaborator
Study Sites (1)
Thammasat University
KlongLaung, Pathumtanee, 12120, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mali - Achariyakul, MD.
Thammasat University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
April 1, 2008
Primary Completion
July 1, 2008
Study Completion
September 1, 2008
Last Updated
June 19, 2008
Record last verified: 2008-06