Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne

Study Overview
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Brief Summary
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Moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid may be beneficial in alternative treatment of acne in maintenance phase. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients.

Detailed Description
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Acne is a chronic inflammatory skin condition. The four main mechanisms that lead to acne include excessive production of sebum from hair follicles, sebum retention, proliferation of Propionibacterium acne, and finally inflammation. Many topical agents are available for treating acute phase of acne. However, only few such as adapalene have been proved to be beneficial in maintenance phase. New active ingredients such as licochalcone, decanediol, L-carnitine, and salicylic acid have been mentioned recently, but there are only few published studies aiming on those ingredients. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients. This study will be divided into 2 phases: induction and maintenance phase. Induction phase One hundred and ten acne vulgaris patients who have mild to moderate severity according to IGA (Investigator's Global Assessment) scale for Acne Vulgaris will be treated with Epiduo® (fixed combination of adapalene 0.1%/benzoyl peroxide 2.5% gel) for 8 weeks. In moderate acne vulgaris cases, 1-2 capsules of oral doxycycline per day will be prescribed. Only patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA grade from baseline will be included in maintenance phase. Maintenance phase Fifty patients will be treated with moisturizer containing active ingredientss on one side of the face and placebo which is moisturizer without active ingredients on the other side according to the randomization for 12 weeks. Patients will be followed up every 4 weeks (week4, week8, week12). The outcome will be assessed by Acne lesion count and severity according to IGA scale. Bioengineering evaluation Stratum corneum hydration will be evaluated by Corneometer® Transepidermal water loss will be evaluated by Tewameter® Sebum will be evaluated by Sebumeter® The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®. The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus) Rating of satisfaction evaluted by VAS score.

Official Title
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A Randomized Controlled Trial of Efficiency of Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne in Thai Acne Subjects

Conditions
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Acne Vulgaris, Acne

Intervention / Treatment
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* Other: Moisturizer with active ingredients
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had age more than 18 years Female patients must use any reliable contraceptive methods except contraceptive pills for at least 1 month prior to the study and 6 months after the completion of the study Being diagnosed acne vulgaris by dermatologist. Patients will be clinically diagnosed with acne vulgaris by dermatologists by presenting of noninflammatory open or closed comedones (blackheads and whiteheads) or inflammatory lesions, which may be papules, pustules, or nodules. Lesions are likely to occur in high concentration of sebaceous glands, for example, face, neck, chest, and back. Inclusion criteria of induction phase 1. Patients who have mild to moderate severity of acne vulgaris according to IGA* (Investigator's Global Assessment) scale of FDA (Food and Drug Administration) at both cheek and diagnosed by dermatologists. IGA* Scale for Acne Vulgaris 0= Clear skin with no inflammatory or noninflammatory lesions rare non-inflammatory lesions with no more than one small inflammatory lesion mild severity defines as some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions) moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion Severe severity defines as up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions Maintenance phase 1. Patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA Grade from baseline Exclusion Criteria: Patients receive antibiotics, systemic treatment for acne such as isotretinoin or contraceptive pills, or spironolactone within 4 weeks prior to the study Patients with active skin disease at face within 2 weeks prior to the study Patients with an allergic to licochalcone A, decanediol, L-carnitine, or salicylic acid Patients with severe and uncontrollable comorbidities Pregnant or breastfeeding women Patients with other types of acne apart from acne vulgaris Patients with an allergic to oral doxycycline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Split face study. Half face is ramdomly applied moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid. Another half face is assigned to use placebo which is moisturizer without those active ingredients.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo and Treatment Arm A<br>The patients in treatment arm A group will be received moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid on the right side of their face and placebo which is moisturizer without those active ingredients on the left side of their face. | Other: Moisturizer with active ingredients<br>* Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day<br>* Other names: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid;Other: Placebo<br>* Placebo: 1 fingertip unit to cover one side of the face twice a day<br>* Other names: Moisturizer without those active ingredients;|
| Active Comparator: Treatment and Placebo Arm B<br>The patients in treatment arm B group will be received moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid on the left side of their face and placebo which is moisturizer without those active ingredients on the right side of their face. | Other: Moisturizer with active ingredients<br>* Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day<br>* Other names: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid;Other: Placebo<br>* Placebo: 1 fingertip unit to cover one side of the face twice a day<br>* Other names: Moisturizer without those active ingredients;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Acne lesion count was evaluated by counting papules, pustules and total number of inflammatory lesions between two sides of face. | 12th week | 
| Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Relapse rate is defined as a percentage of patient who had acne lesion count worse more than 50%. | 12th week | 
| Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Time to relapse is defined as time to which patient had acne lesion count worse more than 50%. | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Side effects are defined as erythema, dryness, scaling, stinging, burning and pruritus. | 12th week | 
| Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Satisfaction is evaluated by overall VAS score. | 12th week | 
| Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation | Skin dyspigmentation is evaluated by Visia® and Antera® which determined melanin and hemoglobin parameters. | 12th week | 
| Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Stratum corneum hydration will be assessed by Corneometer®. The unit is Corneometer® units from 0-130. | 12th week | 
| Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Transepidermal water loss will be assessed by Tewameter® which reported in g/h/m2. | 12th week | 
| Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid | Skin sebum content will be assessed by Sebumeter®. The unit is Sebumeter® units from 0-350 (approximated to μg/cm2 in a certain range). | 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, acne, licochalcone A, decanediol, L-carnitine, salicylic acid