An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Other: Adapalene gel with placebo moisturizer; Other: Adapalene gel; Other: Adapalene gel with Eucerin

Study type: Interventional

Funder types: Other

Identifiers

NCT02173054

Acne and adjuctive moisturizer

Details and patient eligibility

About

Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.

Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).

Full description

The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years old or above
2. Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
3. being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA

Exclusion criteria

1. Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
2. Have other active skin diseases at face during 2 weeks before participate the research
3. Allergic to adapalene gel and moisturizer
4. Have severe or uncontrolled underlying diseases
5. Getting pregnant or during breast feeding
6. Other types of acne(not acne vulgaris)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Adapalene gel

Placebo Comparator group

Description:

Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face

Treatment:

Other: Adapalene gel

Adapalene gel with placebo moisturizer

Placebo Comparator group

Description:

Morning * Wash face by prepared facial foam and dry their face * Apply placebo cream all over the face Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face * Apply placebo cream all over the face

Treatment:

Other: Adapalene gel with placebo moisturizer

Adapalene gel with Eucerin

Active Comparator group

Description:

Morning * Wash face by prepared facial foam and dry their face * Apply Eucerin cream all over the face Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face * Apply Eucerin cream all over the face

Treatment:

Other: Adapalene gel with Eucerin