Overview

This trial is active, not recruiting.

Condition acne
Treatments adapalene gel with eucerin, adapalene gel, adapalene gel with placebo moisturizer
Phase phase 3
Sponsor Mahidol University
Start date July 2014
End date February 2015
Trial size 120 participants
Trial identifier NCT02173054, Acne and adjuctive moisturizer

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face
adapalene gel Adapalene gel (Differin)
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
(Placebo Comparator)
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
adapalene gel with placebo moisturizer •Adapalene gel (Differin)
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
(Active Comparator)
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
adapalene gel with eucerin licochalcone A + L-carnitine + decanediol (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

Primary Outcomes

Measure
Reduction of undesirable effects
time frame: 2nd week, 4th week and 8th week

Secondary Outcomes

Measure
Reduction of severity of acne and oily facial skin
time frame: baseline, 2nd week, 4th week and 8th week

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Papapit Tuchinda, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Mahidol University.