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

Not Applicable

Completed

• Conditions: Acne Vulgaris; Acne
• Interventions: Other: Moisturizer with active ingredients; Other: Placebo

• Registration Number: NCT04002024
• Lead Sponsor: Mahidol University

Brief Summary

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

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

1. Acne lesion count and severity according to IGA scale.

2. Bioengineering evaluation

* Stratum corneum hydration will be evaluated by Corneometer®

* Transepidermal water loss will be evaluated by Tewameter®

* Sebum will be evaluated by Sebumeter®

3. The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®.

4. The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus)

5. Rating of satisfaction evaluted by VAS score.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-27
• Study Start: 2019-06-01
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Primary Completion: 2020-04-01
• Study Completion: 2020-05-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients who had age more than 18 years
2. 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
3. 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

1. rare non-inflammatory lesions with no more than one small inflammatory lesion
2. mild severity defines as some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions)
3. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
4. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
5. 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

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Exclusion Criteria

1. Patients receive antibiotics, systemic treatment for acne such as isotretinoin or contraceptive pills, or spironolactone within 4 weeks prior to the study
2. Patients with active skin disease at face within 2 weeks prior to the study
3. Patients with an allergic to licochalcone A, decanediol, L-carnitine, or salicylic acid
4. Patients with severe and uncontrollable comorbidities
5. Pregnant or breastfeeding women
6. Patients with other types of acne apart from acne vulgaris
7. Patients with an allergic to oral doxycycline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment and Placebo Arm B	Moisturizer with active ingredients	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.
Placebo and Treatment Arm A	Moisturizer with active ingredients	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.
Placebo and Treatment Arm A	Placebo	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.
Treatment and Placebo Arm B	Placebo	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand