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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
Acne lesion count and severity according to IGA scale.
Bioengineering evaluation
Stratum corneum hydration will be evaluated by Corneometer®
Transepidermal water loss will be evaluated by Tewameter®
Sebum will be evaluated by Sebumeter®
The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®.
The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus)
Rating of satisfaction evaluted by VAS score.
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Call 1800-9860-568 now to find out if you are eligible.
Check your eligibility
Take up this questionnaire to help us determine if you have symptoms
that are common to this clinical study. If you have the common
symptoms, you may be eligible to take part in the study.
Age
0 - 100
Gender
Female
NCT ID
TX13621
Phase
1
Status
Recruiting Now
Medical Condition
acne
How is Plaque Psoriasis treated?
Medical Condition
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Learn moreThe Study
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Learn moreAbout Clinical Trials
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Learn moreYour Journey
01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and
then once a week for 12 weeks. Etanercept, as well as study related
medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local
study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after
completing the study. No visits are required after participation is
complete.