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

NCT02173054 | Completed Phase 3 Results DMC

• 1 other identifier: Acne and adjuctive moisturizer
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Acne

Keywords

Acne; Moisturizer; Efficacy; Irritation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Reduction of Severity of Acne

  baseline, 2nd week, 4th week and 8th week

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

  baseline, 2nd week, 4th week and 8th week

Study Arms (3)

Adapalene gel

PLACEBO COMPARATOR

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

Other: Adapalene gel

Adapalene gel with placebo moisturizer

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

Other: Adapalene gel with placebo moisturizer

Adapalene gel with Eucerin

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

Other: Adapalene gel with Eucerin

Interventions

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

Also known as: licochalcone A + L-carnitine + decanediol (Eucerin), Adapalene gel (Differin)

Adapalene gel with Eucerin

Adapalene gel OTHER

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

Also known as: Adapalene gel (Differin)

Adapalene gel

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

Also known as: •Adapalene gel (Differin)

Adapalene gel with placebo moisturizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital Mahidol Univeristy

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 26293170 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

eucerin; licochalcone A; Carnitine; Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Papapit Tuchinda
• Organization: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

papapitt@gmail.com

+662-419-4333

Study Officials

• Papapit Tuchinda, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 24, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 23, 2017
• Results First Posted: February 26, 2016

Record last verified: 2016-11

Locations

TH (1)