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

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

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).

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: Adapalene gel; Other: Adapalene gel with placebo moisturizer; Other: Adapalene gel with Eucerin

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
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital Mahidol Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: •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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2nd week, 4th week, and 8th week
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 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: Transepidermal Water Loss (TEWL)	Skin tolerability was assessed by measuring TEWL with the Tewameter TM300	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 Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 2nd week, 4th week and 8th week
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	baseline, 2nd week, 4th week and 8th week

Collaborators and Investigators

• Sponsor: Mahidol University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Efficacy; Acne; Moisturizer; Irritation
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene
• Other Study ID Numbers: Acne and adjuctive moisturizer