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Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne

NCT ID: NCT00701480

Last Updated: 2008-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Acne

Keywords

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acne skin cleanser Hibiscus sabdariffa Roselle safety efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

skin cleanser contained Hibiscus sabdariffa

Group Type EXPERIMENTAL

skin cleanser contained Hibiscus sabdariffa extract

Intervention Type OTHER

face washing 2-3 times/day

2

marketed skin cleanser

Group Type ACTIVE_COMPARATOR

marketed skin cleanser

Intervention Type OTHER

face washing 2-3 times/day

Interventions

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skin cleanser contained Hibiscus sabdariffa extract

face washing 2-3 times/day

Intervention Type OTHER

marketed skin cleanser

face washing 2-3 times/day

Intervention Type OTHER

Other Intervention Names

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Roselle skin cleanser Clean and Clear Clearasil Neutrogena

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Thammasat University

Principal Investigators

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Mali - Achariyakul, MD.

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Thammasat University

KlongLaung, Pathumtanee, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Mali - Achariyakul, MD.

Role: CONTACT

Phone: 66-02-9269473

Email: [email protected]

Narumol - Teeranulak, MD.

Role: CONTACT

Phone: 66-02-9269474

Email: [email protected]

Facility Contacts

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Mali - Achariyakul, MD.

Role: primary

Narumon Teeranurak, MD.

Role: backup

Other Identifiers

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MTU-E-1-002/51

Identifier Type: -

Identifier Source: org_study_id