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

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ClinicalTrials.gov Identifier: NCT02173054
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : February 26, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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).


Condition or disease Intervention/treatment Phase
Acne Other: Adapalene gel with Eucerin Other: Adapalene gel Other: Adapalene gel with placebo moisturizer Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Placebo Comparator: Adapalene gel

Evening

  • Wash face by prepared facial foam and dry your face
  • Apply adapalene gel all over the face
Other: Adapalene gel
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
Other Name: Adapalene gel (Differin)

Placebo Comparator: 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
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
Other Name: •Adapalene gel (Differin)

Active Comparator: 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
Other: 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
Other Names:
  • licochalcone A + L-carnitine + decanediol (Eucerin)
  • Adapalene gel (Differin)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173054


Locations
Thailand
Siriraj Hospital Mahidol Univeristy
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Papapit Tuchinda, MD Mahidol University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02173054     History of Changes
Other Study ID Numbers: Acne and adjuctive moisturizer
First Posted: June 24, 2014    Key Record Dates
Results First Posted: February 26, 2016
Last Update Posted: January 23, 2017
Last Verified: November 2016

Keywords provided by Mahidol University:
Acne
Moisturizer
Efficacy
Irritation

Additional relevant MeSH terms:
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents