Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002024
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Beiersdorf
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Acne Other: Moisturizer with active ingredients Other: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: Placebo and Treatment Arm A
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
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
Other Name: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid

Other: Placebo
Placebo: 1 fingertip unit to cover one side of the face twice a day
Other Name: Moisturizer without those active ingredients

Active Comparator: Treatment and Placebo Arm B
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
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
Other Name: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid

Other: Placebo
Placebo: 1 fingertip unit to cover one side of the face twice a day
Other Name: Moisturizer without those active ingredients




Primary Outcome Measures :
  1. Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Acne lesion count was evaluated by counting papules, pustules and total number of inflammatory lesions between two sides of face.

  2. Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Relapse rate is defined as a percentage of patient who had acne lesion count worse more than 50%.

  3. Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Time to relapse is defined as time to which patient had acne lesion count worse more than 50%.


Secondary Outcome Measures :
  1. Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Side effects are defined as erythema, dryness, scaling, stinging, burning and pruritus.

  2. Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Satisfaction is evaluated by overall VAS score.

  3. Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation [ Time Frame: 12th week ]
    Skin dyspigmentation is evaluated by Visia® and Antera® which determined melanin and hemoglobin parameters.

  4. Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Stratum corneum hydration will be assessed by Corneometer®. The unit is Corneometer® units from 0-130.

  5. Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 12th week ]
    Transepidermal water loss will be assessed by Tewameter® which reported in g/h/m2.

  6. Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002024


Locations
Layout table for location information
Thailand
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Beiersdorf
Investigators
Layout table for investigator information
Principal Investigator: Kanokvalai Kulthanan, M.D. Mahidol University
Publications:

Layout table for additonal information
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04002024    
Other Study ID Numbers: Eucerine proacne
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
acne vulgaris
acne
licochalcone A
decanediol
L-carnitine
salicylic acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Salicylic Acid
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action