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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Mahidol University
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Updated on 2 May 2025
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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.

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.

Details
Condition Acne Vulgaris, Acne
Age 18years or above
Treatment Placebo, Moisturizer with active ingredients
Clinical Study IdentifierNCT04002024
SponsorMahidol University
Last Modified on2 May 2025

Eligibility

 Yes No Not Sure

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
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

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
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