Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne - Full Text View

Sponsors and Collaborators:	Thammasat University National Research Council of Thailand
Information provided by:	Thammasat University
ClinicalTrials.gov Identifier:	NCT00701480

Purpose

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	Intervention	Phase
Acne	Other: skin cleanser contained Hibiscus sabdariffa extract Other: marketed skin cleanser	Phase II

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment.

Further study details as provided by Thammasat University:

Primary Outcome Measures:

1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental skin cleanser contained Hibiscus sabdariffa	Other: skin cleanser contained Hibiscus sabdariffa extract face washing 2-3 times/day
2: Active Comparator marketed skin cleanser	Other: marketed skin cleanser face washing 2-3 times/day

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.

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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, Pathumtanee
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

No publications provided

Responsible Party:	Thammasat University ( Mali Achariyakul/Dr. )
Study ID Numbers:	MTU-E-1-002/51
Study First Received:	June 17, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00701480 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Thammasat University:

acne
skin cleanser
Hibiscus sabdariffa

Roselle
safety
efficacy

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Benzoyl Peroxide
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Acne Vulgaris

ClinicalTrials.gov processed this record on May 07, 2009