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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173054
• Other study ID #: Acne and adjuctive moisturizer
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2014
• Last updated: January 29, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital Mahidol Univeristy	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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.	Yes
Primary	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.	Yes
Secondary	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	No
Secondary	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	No