Safety and Efficacy of Skin Cleanser Contained Roselle Extract in Acne
Recruitment status was Recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment. |
- 1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- 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 |
|---|---|
|
Experimental: 1
skin cleanser contained Hibiscus sabdariffa
|
Other: skin cleanser contained Hibiscus sabdariffa extract
face washing 2-3 times/day
Other Name: Roselle skin cleanser
|
|
Active Comparator: 2
marketed skin cleanser
|
Other: marketed skin cleanser
face washing 2-3 times/day
Other Names:
|
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 |
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| Contact: Mali - Achariyakul, MD. | 66-02-9269473 | mali1799@hotmail.com |
| Contact: Narumol - Teeranulak, MD. | 66-02-9269474 | narumol-the@yahoo.com |
| Thailand | |
| 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. | |
| Principal Investigator: | Mali - Achariyakul, MD. | Thammasat University |
More Information
No publications provided
| Responsible Party: | Mali Achariyakul/Dr., Thammasat University |
| ClinicalTrials.gov Identifier: | NCT00701480 History of Changes |
| Other Study ID Numbers: | MTU-E-1-002/51 |
| Study First Received: | June 17, 2008 |
| Last Updated: | June 17, 2008 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Thammasat University:
|
acne skin cleanser Hibiscus sabdariffa |
Roselle safety efficacy |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 19, 2013