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Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne

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ClinicalTrials.gov Identifier: NCT00701480
Recruitment Status : Unknown
Verified June 2008 by Thammasat University.
Recruitment status was:  Recruiting
First Posted : June 19, 2008
Last Update Posted : June 19, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acne Other: skin cleanser contained Hibiscus sabdariffa extract Other: marketed skin cleanser Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment.
Study Start Date : April 2008
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
skin cleanser contained Hibiscus sabdariffa
Other: skin cleanser contained Hibiscus sabdariffa extract
face washing 2-3 times/day
Other Name: Roselle skin cleanser
Active Comparator: 2
marketed skin cleanser
Other: marketed skin cleanser
face washing 2-3 times/day
Other Names:
  • Clean and Clear
  • Clearasil
  • Neutrogena


Outcome Measures

Primary Outcome Measures :
  1. 1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701480


Contacts
Contact: Mali - Achariyakul, MD. 66-02-9269473 mali1799@hotmail.com
Contact: Narumol - Teeranulak, MD. 66-02-9269474 narumol-the@yahoo.com

Locations
Thailand
Thammasat University Recruiting
KlongLaung, Pathumtanee, Thailand, 12120
Contact: Mali - Achariyakul, MD.    66-02-9269473    mali1799@hotmail.com   
Contact: Narumon Teeranurak, MD.    66-02-9269474      
Sub-Investigator: Narumon - Teeranurak, MD.         
Sub-Investigator: Vareeporn - Dispanurat, MD.         
Sponsors and Collaborators
Thammasat University
National Research Council of Thailand
Investigators
Principal Investigator: Mali - Achariyakul, MD. Thammasat University
More Information

Responsible Party: Mali Achariyakul/Dr., Thammasat University
ClinicalTrials.gov Identifier: NCT00701480     History of Changes
Other Study ID Numbers: MTU-E-1-002/51
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008

Keywords provided by Thammasat University:
acne
skin cleanser
Hibiscus sabdariffa
Roselle
safety
efficacy