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.

Study Overview

• Status: Unknown
• Conditions: Acne
• Intervention / Treatment: Other: skin cleanser contained Hibiscus sabdariffa extract; Other: marketed skin cleanser

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mali - Achariyakul, MD.; Phone Number: 66-02-9269473; Email: mali1799@hotmail.com
• Study Contact Backup: Name: Narumol - Teeranulak, MD.; Phone Number: 66-02-9269474; Email: narumol-the@yahoo.com

Study Locations

• Thailand
  • Pathumtanee
    • KlongLaung, Pathumtanee, Thailand, 12120
      • Recruiting
      • Thammasat University
      • Contact: Mali - Achariyakul, MD.; Phone Number: 66-02-9269473; Email: mali1799@hotmail.com
      • Contact: Narumon Teeranurak, MD.; Phone Number: 66-02-9269474
      • Sub-Investigator: Narumon - Teeranurak, MD.
      • Sub-Investigator: Vareeporn - Dispanurat, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; skin cleanser contained Hibiscus sabdariffa	Other: skin cleanser contained Hibiscus sabdariffa extract; face washing 2-3 times/day; Other Names: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Safety evaluation: "a." Skin properties by visual and tactile features., "b." Biophysical parameters of skin. 2.Efficacy evaluation: Patient assessments.	6 weeks

Collaborators and Investigators

• Sponsor: Thammasat University
• Collaborators: National Research Council of Thailand
• Investigators: Principal Investigator: Mali - Achariyakul, MD., Thammasat University

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Anticipated): September 1, 2008

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 17, 2008
• First Posted (Estimate): June 19, 2008

Study Record Updates

• Last Update Posted (Estimate): June 19, 2008
• Last Update Submitted That Met QC Criteria: June 17, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: safety; efficacy; acne; Hibiscus sabdariffa; skin cleanser; Roselle
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: MTU-E-1-002/51