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

NCT04002024 | Completed

• 1 other identifier: Eucerine proacne
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris; Acne

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

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

  12th week

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

  12th week

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

  12th week

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

  12th week

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

  12th week

Study Arms (2)

Placebo and Treatment Arm A

ACTIVE COMPARATOR

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; Other: Placebo

Treatment and Placebo Arm B

ACTIVE COMPARATOR

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; Other: Placebo

Interventions

Moisturizer with active ingredients OTHER

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

Also known as: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid

Placebo and Treatment Arm A; Treatment and Placebo Arm B

Placebo OTHER

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

Also known as: Moisturizer without those active ingredients

Placebo and Treatment Arm A; Treatment and Placebo Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Beiersdorf: collaborator

Study Sites (1)

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

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (11)

• Clark AK, Saric S, Sivamani RK. Acne Scars: How Do We Grade Them? Am J Clin Dermatol. 2018 Apr;19(2):139-144. doi: 10.1007/s40257-017-0321-x.

  PMID: 28891036 BACKGROUND

• Tan JK, Tang J, Fung K, Gupta AK, Thomas DR, Sapra S, Lynde C, Poulin Y, Gulliver W, Sebaldt RJ. Development and validation of a comprehensive acne severity scale. J Cutan Med Surg. 2007 Nov-Dec;11(6):211-6. doi: 10.2310/7750.2007.00037.

  PMID: 18042334 BACKGROUND

• Zhang JZ, Li LF, Tu YT, Zheng J. A successful maintenance approach in inflammatory acne with adapalene gel 0.1% after an initial treatment in combination with clindamycin topical solution 1% or after monotherapy with clindamycin topical solution 1%. J Dermatolog Treat. 2004 Dec;15(6):372-8. doi: 10.1080/09546630410021702.

  PMID: 15764049 BACKGROUND

• Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Kerrouche N, Arsonnaud S, Kang S. Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study. Arch Dermatol. 2006 May;142(5):597-602. doi: 10.1001/archderm.142.5.597.

  PMID: 16702497 BACKGROUND

• Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007 Jul;21(6):747-53. doi: 10.1111/j.1468-3083.2007.02190.x.

  PMID: 17567301 BACKGROUND

• Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.

  PMID: 29549588 BACKGROUND

• Bhatia N, Bhatt V, Martin G, Pillai R. Two Randomized, Double-Blind, Split-Face Studies to Compare the Irritation Potential of Two Topical Acne Fixed Combinations Over a 21-Day Treatment Period. J Drugs Dermatol. 2016 Jun 1;15(6):721-6.

  PMID: 27272079 BACKGROUND

• Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.

  PMID: 26293170 BACKGROUND

• Chen X, Wang S, Yang M, Li L. Chemical peels for acne vulgaris: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 28;8(4):e019607. doi: 10.1136/bmjopen-2017-019607.

  PMID: 29705755 BACKGROUND

• Matsunaga K, Leow YH, Chan R, Kerrouche N, Paliargues F. Adjunctive usage of a non-comedogenic moisturizer with adapalene gel 0.1% improves local tolerance: a randomized, investigator-blinded, split-face study in healthy Asian subjects. J Dermatolog Treat. 2013 Aug;24(4):278-82. doi: 10.3109/09546634.2012.661037. Epub 2012 Mar 4.

  PMID: 22384983 BACKGROUND

• Kulthanan K, Trakanwittayarak S, Tuchinda P, Chularojanamontri L, Limphoka P, Varothai S. A Double-Blinded, Randomized, Vehicle-Controlled Study of the Efficacy of Moisturizer Containing Licochalcone A, Decanediol, L-Carnitine, and Salicylic Acid for Prevention of Acne Relapse in Asian Population. Biomed Res Int. 2020 Oct 16;2020:2857812. doi: 10.1155/2020/2857812. eCollection 2020.

  PMID: 33150170 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Carnitine; Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Kanokvalai Kulthanan, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: June 28, 2019
• Study Start: June 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

TH (1)