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An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne
Plain-language guide to NCT02173054: phase 3 randomized trial of L-Carnitine, acne, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02173054
- Phase
- phase 3
- Status
- completed
- Start
- 2014-07
- Completion (planned or actual)
- 2015-02
- Participants
- 120 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Acne
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test L-Carnitine for acne.
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.
It had three arms (groups): Adapalene gel (placebo comparator), Adapalene gel with placebo moisturizer (placebo comparator) and Adapalene gel with Eucerin (active comparator).
Evening * Wash face by prepared facial foam and dry your face * Apply adapalene gel all over the face.
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.
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.
The registry classes the interventions as other.
More on the Plan
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.
Who Took Part
The registry lists 120 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: 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.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the acne participants stayed in one arm throughout.
As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2014-07 with completion listed for 2015-02.
It ran at 1 site in Thailand.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Skin Tolerability: Skin Sebum Content and Skin Hydration. Skin Tolerability: Transepidermal Water Loss (TEWL).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of L-Carnitine in 120 people with acne.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the L-Carnitine compound page, Acne research.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.