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Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne
Plain-language guide to NCT04002024: not phased randomized trial of L-Carnitine, acne, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04002024
- Phase
- not phased
- Status
- completed
- Start
- 2019-06-01
- Completion (planned or actual)
- 2020-04-01
- Participants
- 50 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Acne Vulgaris; Acne
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested L-Carnitine for acne.
It had two arms (groups): Placebo and Treatment Arm A (active comparator) and Treatment and Placebo Arm B (active comparator).
The patients in treatment arm A group will be received moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid on the right side of their face and placebo which is moisturizer without those active ingredients on the left side of their face.
The patients in treatment arm B group will be received moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid on the left side of their face and placebo which is moisturizer without those active ingredients on the right side of their face.
The registry classes the interventions as other.
More on the Plan
Acne is a chronic inflammatory skin condition.
The four main mechanisms that lead to acne include excessive production of sebum from hair follicles, sebum retention, proliferation of Propionibacterium acne, and finally inflammation.
Many topical agents are available for treating acute phase of acne.
New active ingredients such as licochalcone, decanediol, L-carnitine, and salicylic acid have been mentioned recently, but there are only few published studies aiming on those ingredients.
Who Took Part
The registry lists 50 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: Patients who had age more than 18 years. Female patients must use any reliable contraceptive methods except contraceptive pills for at least 1 month prior to the study and 6 months after the completion of the study. Rare non-inflammatory lesions with no more than one small inflammatory lesion. Mild severity defines as some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions). Moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.
The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: patients receive antibiotics, systemic treatment for acne such as isotretinoin or contraceptive pills, or spironolactone within 4 weeks prior to the study; patients with active skin disease at face within 2 weeks prior to the study; patients with an allergic to licochalcone a, decanediol, l-carnitine, or salicylic acid.
How the Study Was Run
It was run as a randomized, crossover and quadruple-blind study.
Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.
In the crossover set-up each of the acne participants took both L-Carnitine and the comparison in turn, acting as their own control.
Blinding on both sides kept the acne participants and researchers unaware of who received L-Carnitine.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2019-06-01 with completion listed for 2020-04-01.
It ran at 1 site in Thailand.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid (time frame: 12th week). Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid (time frame: 12th week).
It also tracked 6 secondary outcomes, for example Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid and Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of L-Carnitine in 50 people with acne.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.