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

NCT ID: NCT02173054

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

Brief Summary

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).

Detailed 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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adapalene gel

Evening

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

Group Type: PLACEBO_COMPARATOR

Adapalene gel

Intervention Type: OTHER

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Adapalene gel with placebo moisturizer

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

Group Type: PLACEBO_COMPARATOR

Adapalene gel with placebo moisturizer

Intervention Type: OTHER

Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Adapalene gel with Eucerin

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

Group Type: ACTIVE_COMPARATOR

Adapalene gel with Eucerin

Intervention Type: OTHER

Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Interventions

Adapalene gel with Eucerin

Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Intervention Type: OTHER

Adapalene gel

Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Intervention Type: OTHER

Adapalene gel with placebo moisturizer

Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Intervention Type: OTHER

Other Intervention Names

licochalcone A + L-carnitine + decanediol (Eucerin); Adapalene gel (Differin); Adapalene gel (Differin); •Adapalene gel (Differin)

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Papapit Tuchinda, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Siriraj Hospital Mahidol Univeristy

Bangkok, Bangkok, Thailand

Countries

Thailand

References

Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.

Reference Type: DERIVED

PMID: 26293170 (View on PubMed)

Other Identifiers

Acne and adjuctive moisturizer

Identifier Type: -

Identifier Source: org_study_id