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

Primary Purpose

Acne

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Adapalene gel with Eucerin
Adapalene gel
Adapalene gel with placebo moisturizer
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne, Moisturizer, Efficacy, Irritation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Siriraj Hospital Mahidol Univeristy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Arm Label

Adapalene gel

Adapalene gel with placebo moisturizer

Adapalene gel with Eucerin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Reduction of Undesirable Effects
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.
Skin Tolerability: Skin Sebum Content and Skin Hydration
Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Skin Tolerability: Transepidermal Water Loss (TEWL)
Skin tolerability was assessed by measuring TEWL with the Tewameter TM300

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2014
Last Updated
November 28, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02173054
Brief Title
An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne, Moisturizer, Efficacy, Irritation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapalene gel
Arm Type
Placebo Comparator
Arm Description
Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face
Arm Title
Adapalene gel with placebo moisturizer
Arm Type
Placebo Comparator
Arm 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
Arm Title
Adapalene gel with Eucerin
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Adapalene gel with Eucerin
Other Intervention Name(s)
licochalcone A + L-carnitine + decanediol (Eucerin), Adapalene gel (Differin)
Intervention Description
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
Intervention Name(s)
Adapalene gel
Other Intervention Name(s)
Adapalene gel (Differin)
Intervention Description
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
Intervention Type
Other
Intervention Name(s)
Adapalene gel with placebo moisturizer
Other Intervention Name(s)
•Adapalene gel (Differin)
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of Undesirable Effects
Description
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.
Time Frame
2nd week, 4th week, and 8th week
Title
Skin Tolerability: Skin Sebum Content and Skin Hydration
Description
Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
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.
Title
Skin Tolerability: Transepidermal Water Loss (TEWL)
Description
Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
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.
Secondary Outcome Measure Information:
Title
Reduction of Severity of Acne
Description
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
Time Frame
baseline, 2nd week, 4th week and 8th week
Title
Reduction of Severity of Acne: Acne Severity Index (ASI)
Description
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
Time Frame
baseline, 2nd week, 4th week and 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Papapit Tuchinda, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital Mahidol Univeristy
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26293170
Citation
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.
Results Reference
derived

Learn more about this trial

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

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