Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Research Council of Thailand
Information provided by:
Thammasat University

June 17, 2008
June 19, 2008
June 19, 2008
April 2008
July 2008   (Final data collection date for primary outcome measure)
1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading [ Time Frame: 6 weeks ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
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.
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Other: skin cleanser contained Hibiscus sabdariffa extract
    face washing 2-3 times/day
    Other Name: Roselle skin cleanser
  • Other: marketed skin cleanser
    face washing 2-3 times/day
    Other Names:
    • Clean and Clear
    • Clearasil
    • Neutrogena
  • Experimental: 1
    skin cleanser contained Hibiscus sabdariffa
    Intervention: Other: skin cleanser contained Hibiscus sabdariffa extract
  • Active Comparator: 2
    marketed skin cleanser
    Intervention: Other: marketed skin cleanser
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 45 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Mali Achariyakul/Dr., Thammasat University
Thammasat University
National Research Council of Thailand
Principal Investigator: Mali - Achariyakul, MD. Thammasat University
Thammasat University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP