Clinical trial NCT04002024: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Acne
Keywords: acne vulgaris
acne
licochalcone A
decanediol
L-carnitine
salicylic acid
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Beiersdorf
First posted: 2019-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
Secondary outcomes:
measure: Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation
timeFrame: 12th week
measure: Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
measure: Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
timeFrame: 12th week
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Kanokvalai Kulthanan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.