Acne Vulgaris Clinical Trial
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
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.
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.
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