Phase 3
N=120
An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne
Acne
Bottom Line
View on ClinicalTrials.gov: NCT02173054 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Reduction of Undesirable Effects — 26; 38; 35; 10 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adapalene gel with Eucerin (Other); Adapalene gel (Other); Adapalene gel with placebo moisturizer (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Undesirable Effects |
26; 38; 35; 10; 2; 4 | 0.001 sig |
| PRIMARY Skin Tolerability: Skin Sebum Content and Skin Hydration |
75.7; 71.2; 73.7; 63.6; 59.9; 64.2 | 0.078 |
| PRIMARY Skin Tolerability: Transepidermal Water Loss (TEWL) |
9.8; 10.4; 10.6; 12.3; 11.8; 11.5 | 0.0002 sig |
| SECONDARY Reduction of Severity of Acne |
35.9; 27.4; 25.5; 41; 26.6; 23.8 | 0.059 |
| SECONDARY Reduction of Severity of Acne: Acne Severity Index (ASI) |
11.7; 9.4; 9.5; 14.4; 10.4; 8.7 | 0.005 sig |
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).
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)
Data sourced from ClinicalTrials.gov (NCT02173054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.