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Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne

Primary Purpose

Acne

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
skin cleanser contained Hibiscus sabdariffa extract
marketed skin cleanser
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acne focused on measuring acne, skin cleanser, Hibiscus sabdariffa, Roselle, safety, efficacy

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thammasat UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

skin cleanser contained Hibiscus sabdariffa

marketed skin cleanser

Outcomes

Primary Outcome Measures

1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2008
Last Updated
June 17, 2008
Sponsor
Thammasat University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT00701480
Brief Title
Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne
Official Title
Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Thammasat University
Collaborators
National Research Council of Thailand

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
acne, skin cleanser, Hibiscus sabdariffa, Roselle, safety, efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
skin cleanser contained Hibiscus sabdariffa
Arm Title
2
Arm Type
Active Comparator
Arm Description
marketed skin cleanser
Intervention Type
Other
Intervention Name(s)
skin cleanser contained Hibiscus sabdariffa extract
Other Intervention Name(s)
Roselle skin cleanser
Intervention Description
face washing 2-3 times/day
Intervention Type
Other
Intervention Name(s)
marketed skin cleanser
Other Intervention Name(s)
Clean and Clear, Clearasil, Neutrogena
Intervention Description
face washing 2-3 times/day
Primary Outcome Measure Information:
Title
1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mali - Achariyakul, MD.
Phone
66-02-9269473
Email
mali1799@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Narumol - Teeranulak, MD.
Phone
66-02-9269474
Email
narumol-the@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mali - Achariyakul, MD.
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University
City
KlongLaung
State/Province
Pathumtanee
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mali - Achariyakul, MD.
Phone
66-02-9269473
Email
mali1799@hotmail.com
First Name & Middle Initial & Last Name & Degree
Narumon Teeranurak, MD.
Phone
66-02-9269474
First Name & Middle Initial & Last Name & Degree
Narumon - Teeranurak, MD.
First Name & Middle Initial & Last Name & Degree
Vareeporn - Dispanurat, MD.

12. IPD Sharing Statement

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Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne

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