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NCT Number: NCT02173054

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

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).

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Siriraj Hospital Mahidol Univeristy

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years old or above
  • 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.
  • being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA

Exclusion criteria

  • 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
  • Have other active skin diseases at face during 2 weeks before participate the research
  • Allergic to adapalene gel and moisturizer
  • Have severe or uncontrolled underlying diseases
  • Getting pregnant or during breast feeding
  • Other types of acne(not acne vulgaris)

Treatment and study plan

Adapalene gel with Eucerin

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

Other names: licochalcone A + L-carnitine + decanediol (Eucerin), Adapalene gel (Differin)

Adapalene gel

Other

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

Other names: Adapalene gel (Differin)

Adapalene gel with placebo moisturizer

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

Other names: •Adapalene gel (Differin)

Primary outcomes

  1. Reduction of Undesirable Effects

    Time frame: 2nd week, 4th week, and 8th week

    • Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
    • The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.

  2. Skin Tolerability: Skin Sebum Content and Skin Hydration

    Time frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.

    Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively

  3. Skin Tolerability: Transepidermal Water Loss (TEWL)

    Time frame: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.

    Skin tolerability was assessed by measuring TEWL with the Tewameter TM300

Secondary outcomes

  1. Reduction of Severity of Acne

    Time frame: baseline, 2nd week, 4th week and 8th week

    • Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
    • Total acne lesions = inflammatory + noninflammatory acne lesions
    • Reduction of lesions counts are considered to be a better outcome

  2. Reduction of Severity of Acne: Acne Severity Index (ASI)

    Time frame: baseline, 2nd week, 4th week and 8th week

    • The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
    • Decrease of ASI score are considered to be a better outcome

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

An Evaluator-blind, Randomized, Vehicle-controlled Efficiency of Adjunctive Usage of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel for Improvement of Local Tolerance in Thai Acne Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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