NCT04002024

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris
• Acne

Interventions

Type	Name	Description
OTHER	Moisturizer with active ingredients	Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
OTHER	Placebo	Placebo: 1 fingertip unit to cover one side of the face twice a day

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2019-06-28
• Last updated: 2020-09-04

Locations

1 site across 1 country: Thailand