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In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)
Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.
Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications.However, previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis.
To compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)
Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind split-face clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFCO application | Experimental | We made LFCO application(Lactobacillus Fermented Chamaecypris obtusa) containing cream to one side of patients' face to monitor effectiveness and safety in acne treatment. |
|
| TTO application | Active Comparator | To compare effectiveness and safety of new LFCO, we applied existing TTO containing cream to the other side of face in the same patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFCO application | Other | Application of LFCO (Lactobacillus fermented Chamaecypris obtusa ) containing creams to one randomly selected face of patients to monitor its effectiveness and safety of acne treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of inflammatory and non-inflammatory acne lesions | Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness & safety of two botanical compounds | total 8 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's subjective assessments for comfortableness & efficacy | Patients are required to report subjective assessments for comfortableness & efficacy for two creams they used | 8 weeks after baseline |
| Sebum secretion assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Hun Sun, MD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Seoul National University College of Medicine | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22168326 | Result | Hayashi N, Kawashima M. Multicenter randomized controlled trial on combination therapy with 0.1% adapalene gel and oral antibiotics for acne vulgaris: comparison of the efficacy of adapalene gel alone and in combination with oral faropenem. J Dermatol. 2012 Jun;39(6):511-5. doi: 10.1111/j.1346-8138.2011.01450.x. Epub 2011 Dec 14. | |
| 17314442 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| TTO application | Other | Application of TTO (Tea tree oil) containing creams to the other side of face of patients to monitor its effectiveness and safe compared with LFCO. |
|
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Patients' sebum secretion from face was measured by sebumeter to detect sebum secretion changes after applying two components.
| 8 weeks after baseline |
| Histopathologic analysis | changes of tissue after application of two creams | 8 weeks after baseline |
| Adverse effects | patients' reportings for severe side effects after application of two creams was monitored. | 8 weeks after baseline |
| Enshaieh S, Jooya A, Siadat AH, Iraji F. The efficacy of 5% topical tea tree oil gel in mild to moderate acne vulgaris: a randomized, double-blind placebo-controlled study. Indian J Dermatol Venereol Leprol. 2007 Jan-Feb;73(1):22-5. doi: 10.4103/0378-6323.30646. |