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

Primary Purpose

Acne Vulgaris, Acne

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Moisturizer with active ingredients

Placebo

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, acne, licochalcone A, decanediol, L-carnitine, salicylic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Placebo and Treatment Arm A

Treatment and Placebo Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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%.

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%.

Secondary Outcome Measures

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.

Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Satisfaction is evaluated by overall VAS score.

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.

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.

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.

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).

Full Information

NCT ID

NCT04002024

First Posted

February 27, 2019

Last Updated

September 2, 2020

Sponsor

Mahidol University

Collaborators

Beiersdorf

1. Study Identification

Unique Protocol Identification Number

NCT04002024

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

Beiersdorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris, Acne

Keywords

acne vulgaris, acne, licochalcone A, decanediol, L-carnitine, salicylic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo and Treatment Arm A

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment and Placebo Arm B

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Moisturizer with active ingredients

Other Intervention Name(s)

Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid

Intervention Description

Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Moisturizer without those active ingredients

Intervention Description

Placebo: 1 fingertip unit to cover one side of the face twice a day

Primary Outcome Measure Information:

Title

Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Acne lesion count was evaluated by counting papules, pustules and total number of inflammatory lesions between two sides of face.

Time Frame

12th week

Title

Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Relapse rate is defined as a percentage of patient who had acne lesion count worse more than 50%.

Time Frame

12th week

Title

Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Time to relapse is defined as time to which patient had acne lesion count worse more than 50%.

Time Frame

12th week

Secondary Outcome Measure Information:

Title

Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Side effects are defined as erythema, dryness, scaling, stinging, burning and pruritus.

Time Frame

12th week

Title

Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Satisfaction is evaluated by overall VAS score.

Time Frame

12th week

Title

Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation

Description

Skin dyspigmentation is evaluated by Visia® and Antera® which determined melanin and hemoglobin parameters.

Time Frame

12th week

Title

Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Stratum corneum hydration will be assessed by Corneometer®. The unit is Corneometer® units from 0-130.

Time Frame

12th week

Title

Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Transepidermal water loss will be assessed by Tewameter® which reported in g/h/m2.

Time Frame

12th week

Title

Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid

Description

Skin sebum content will be assessed by Sebumeter®. The unit is Sebumeter® units from 0-350 (approximated to μg/cm2 in a certain range).

Time Frame

12th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kanokvalai Kulthanan, M.D.

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

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28891036

Citation

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Results Reference

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Citation

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Citation

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

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