Acne VulgarisNCT04002024
Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne
A study testing Moisturizer with active ingredients in people with Acne Vulgaris and Acne, run by Mahidol University at 1 site in Thailand.
Trial summary
Moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid may be beneficial in alternative treatment of acne in maintenance phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris, Acne
- What is being tested?
- Moisturizer with active ingredients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- Being diagnosed acne vulgaris by dermatologist. Patients will be clinically diagnosed with acne vulgaris by dermatologists by presenting of noninflammatory open or closed comedones (blackheads and whiteheads) or inflammatory lesions, which may be papules, pustules, or nodules. Lesions are likely to occur in high concentration of sebaceous glands, for example, face, neck, chest, and back.
- 1. Patients who have mild to moderate severity of acne vulgaris according to IGA (Investigator's Global Assessment) scale of FDA (Food and Drug Administration) at both cheek and diagnosed by dermatologists.
- IGA Scale for Acne Vulgaris 0= Clear skin with no inflammatory or noninflammatory lesions
- rare non-inflammatory lesions with no more than one small inflammatory lesion
Show all 12Show fewer
- 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
- moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
- Severe severity defines as up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions
- Maintenance phase
- 1. Patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA Grade from baseline
Who cannot join
- 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
- Patients with severe and uncontrollable comorbidities
- Pregnant or breastfeeding women
- Patients with other types of acne apart from acne vulgaris
- Patients with an allergic to oral doxycycline
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: A Randomized Controlled Trial of Efficiency of Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne in Thai Acne Subjects
Moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid may be beneficial in alternative treatment of acne in maintenance phase. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients.
Read the detailed description
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. However, only few such as adapalene have been proved to be beneficial in maintenance phase. 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. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients. This study will be divided into 2 phases: induction and maintenance phase.
Induction phase
One hundred and ten acne vulgaris patients who have mild to moderate severity according to IGA (Investigator's Global Assessment) scale for Acne Vulgaris will be treated with Epiduo® (fixed combination of adapalene 0.1%/benzoyl peroxide 2.5% gel) for 8 weeks. In moderate acne vulgaris cases, 1-2 capsules of oral doxycycline per day will be prescribed. Only patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA grade from baseline will be included in maintenance phase.
Maintenance phase
Fifty patients will be treated with moisturizer containing active ingredientss on one side of the face and placebo which is moisturizer without active ingredients on the other side according to the randomization for 12 weeks. Patients will be followed up every 4 weeks (week4, week8, week12). The outcome will be assessed by
- Acne lesion count and severity according to IGA scale.
- Bioengineering evaluation
- Stratum corneum hydration will be evaluated by Corneometer®
- Transepidermal water loss will be evaluated by Tewameter®
- Sebum will be evaluated by Sebumeter®
- The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®.
- The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus)
- Rating of satisfaction evaluted by VAS score.
- Conditions
- Acne Vulgaris, Acne
- Being tested
- Moisturizer with active ingredients, Placebo
- Keywords
- acne vulgaris, acne, licochalcone A, decanediol, L-carnitine, salicylic acid
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizer with active ingredientsOther
Also called Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
PlaceboOther
Also called Moisturizer without those active ingredients
Placebo: 1 fingertip unit to cover one side of the face twice a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Treatment Arm A | 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. Receives: Other: Moisturizer with active ingredients; Other: Placebo |
| Treatment and Placebo Arm B | Active comparator | 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. Receives: Other: Moisturizer with active ingredients; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Acne lesion count was evaluated by counting papules, pustules and total number of inflammatory lesions between two sides of face.
Measured: 12th week
Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Relapse rate is defined as a percentage of patient who had acne lesion count worse more than 50%.
Measured: 12th week
Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time to relapse is defined as time to which patient had acne lesion count worse more than 50%.
Measured: 12th week
Secondary outcomes (6)
Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Side effects are defined as erythema, dryness, scaling, stinging, burning and pruritus.
Measured: 12th week
Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Satisfaction is evaluated by overall VAS score.
Measured: 12th week
Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation
Skin dyspigmentation is evaluated by Visia® and Antera® which determined melanin and hemoglobin parameters.
Measured: 12th week
Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Stratum corneum hydration will be assessed by Corneometer®. The unit is Corneometer® units from 0-130.
Measured: 12th week
Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Transepidermal water loss will be assessed by Tewameter® which reported in g/h/m2.
Measured: 12th week
Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Skin sebum content will be assessed by Sebumeter®. The unit is Sebumeter® units from 0-350 (approximated to μg/cm2 in a certain range).
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split face study. Half face is ramdomly applied moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid. Another half face is assigned to use placebo which is moisturizer without those active ingredients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Beiersdorf
- Responsible party
- Sponsor
- Investigators
- Kanokvalai Kulthanan, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002024
- Sponsor's protocol ID
- Eucerine proacne
- Status last verified
- Sep 2020
- First submitted
- 27 Feb 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clark AK, Saric S, Sivamani RK. Acne Scars: How Do We Grade Them? Am J Clin Dermatol. 2018 Apr;19(2):139-144. doi: 10.1007/s40257-017-0321-x.
PubMed 28891036Tan JK, Tang J, Fung K, Gupta AK, Thomas DR, Sapra S, Lynde C, Poulin Y, Gulliver W, Sebaldt RJ. Development and validation of a comprehensive acne severity scale. J Cutan Med Surg. 2007 Nov-Dec;11(6):211-6. doi: 10.2310/7750.2007.00037.
PubMed 18042334Zhang JZ, Li LF, Tu YT, Zheng J. A successful maintenance approach in inflammatory acne with adapalene gel 0.1% after an initial treatment in combination with clindamycin topical solution 1% or after monotherapy with clindamycin topical solution 1%. J Dermatolog Treat. 2004 Dec;15(6):372-8. doi: 10.1080/09546630410021702.
PubMed 15764049Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Kerrouche N, Arsonnaud S, Kang S. Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study. Arch Dermatol. 2006 May;142(5):597-602. doi: 10.1001/archderm.142.5.597.
PubMed 16702497Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007 Jul;21(6):747-53. doi: 10.1111/j.1468-3083.2007.02190.x.
PubMed 17567301Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.
PubMed 29549588Bhatia N, Bhatt V, Martin G, Pillai R. Two Randomized, Double-Blind, Split-Face Studies to Compare the Irritation Potential of Two Topical Acne Fixed Combinations Over a 21-Day Treatment Period. J Drugs Dermatol. 2016 Jun 1;15(6):721-6.
PubMed 27272079Chularojanamontri 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.
PubMed 26293170Chen X, Wang S, Yang M, Li L. Chemical peels for acne vulgaris: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 28;8(4):e019607. doi: 10.1136/bmjopen-2017-019607.
PubMed 29705755Matsunaga K, Leow YH, Chan R, Kerrouche N, Paliargues F. Adjunctive usage of a non-comedogenic moisturizer with adapalene gel 0.1% improves local tolerance: a randomized, investigator-blinded, split-face study in healthy Asian subjects. J Dermatolog Treat. 2013 Aug;24(4):278-82. doi: 10.3109/09546634.2012.661037. Epub 2012 Mar 4.
PubMed 22384983Kulthanan K, Trakanwittayarak S, Tuchinda P, Chularojanamontri L, Limphoka P, Varothai S. A Double-Blinded, Randomized, Vehicle-Controlled Study of the Efficacy of Moisturizer Containing Licochalcone A, Decanediol, L-Carnitine, and Salicylic Acid for Prevention of Acne Relapse in Asian Population. Biomed Res Int. 2020 Oct 16;2020:2857812. doi: 10.1155/2020/2857812. eCollection 2020.
PubMed 33150170
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Efficiency of Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne in Thai Acne Subjects
- ClinicalTrials.gov ID
- NCT04002024
- Acronym / sponsor ID
- Eucerine proacne
- Conditions
- Acne Vulgaris, Acne
- Keywords
- acne vulgaris, acne, licochalcone A, decanediol, L-carnitine, salicylic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Beiersdorf
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid may be beneficial in alternative treatment of acne in maintenance phase. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients.
Detailed description
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. However, only few such as adapalene have been proved to be beneficial in maintenance phase. 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. This study aims to evaluate the efficacy and safety of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid during the maintenance phase of acne in Thai patients. This study will be divided into 2 phases: induction and maintenance phase.
Induction phase
One hundred and ten acne vulgaris patients who have mild to moderate severity according to IGA (Investigator's Global Assessment) scale for Acne Vulgaris will be treated with Epiduo® (fixed combination of adapalene 0.1%/benzoyl peroxide 2.5% gel) for 8 weeks. In moderate acne vulgaris cases, 1-2 capsules of oral doxycycline per day will be prescribed. Only patients who have at least 50 percent reduction in numbers of acne vulgaris or at least 2 grade improvement according to IGA grade from baseline will be included in maintenance phase.
Maintenance phase
Fifty patients will be treated with moisturizer containing active ingredientss on one side of the face and placebo which is moisturizer without active ingredients on the other side according to the randomization for 12 weeks. Patients will be followed up every 4 weeks (week4, week8, week12). The outcome will be assessed by
- Acne lesion count and severity according to IGA scale.
- Bioengineering evaluation
- Stratum corneum hydration will be evaluated by Corneometer®
- Transepidermal water loss will be evaluated by Tewameter®
- Sebum will be evaluated by Sebumeter®
- The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®.
- The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus)
- Rating of satisfaction evaluted by VAS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split face study. Half face is ramdomly applied moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid. Another half face is assigned to use placebo which is moisturizer without those active ingredients.
| Arm | Type | Receives |
|---|---|---|
| Placebo and Treatment Arm A | Active comparator | Other: Moisturizer with active ingredients, Other: PlaceboThe 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. |
| Treatment and Placebo Arm B | Active comparator | Other: Moisturizer with active ingredients, Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Being diagnosed acne vulgaris by dermatologist. Patients will be clinically diagnosed with acne vulgaris by dermatologists by presenting of noninflammatory open or closed comedones (blackheads and whiteheads) or inflammatory lesions, which may be papules, pustules, or nodules. Lesions are likely to occur in high concentration of sebaceous glands, for example, face, neck, chest, and back.
- 1. Patients who have mild to moderate severity of acne vulgaris according to IGA (Investigator's Global Assessment) scale of FDA (Food and Drug Administration) at both cheek and diagnosed by dermatologists.
- IGA Scale for Acne Vulgaris 0= Clear skin with no inflammatory or noninflammatory lesions
Key exclusion criteria (7 listed)
- 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
- Patients with severe and uncontrollable comorbidities
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moisturizer with active ingredientsAlso: Moisturizer containing Licochalcone A, Decanediol, L-carnitine and Salicylic AcidMoisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day | Other | Placebo and Treatment Arm A, Treatment and Placebo Arm B |
| PlaceboAlso: Moisturizer without those active ingredientsPlacebo: 1 fingertip unit to cover one side of the face twice a day | Other | Placebo and Treatment Arm A, Treatment and Placebo Arm B |
Primary outcome
Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Acne lesion count was evaluated by counting papules, pustules and total number of inflammatory lesions between two sides of face.
Relapse rate of acne of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Relapse rate is defined as a percentage of patient who had acne lesion count worse more than 50%.
Time to acne relapse of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Time to relapse is defined as time to which patient had acne lesion count worse more than 50%.
6 secondary outcomes
Side effects of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Patients' satisfaction of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Efficacy of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid in reducing skin dyspigmentation
Time frame: 12th week
Stratum corneum hydration during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Transepidermal water loss during the use of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Skin sebum content during the use of moisturizer containingthe active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 28891036Clark AK, Saric S, Sivamani RK. Acne Scars: How Do We Grade Them? Am J Clin Dermatol. 2018 Apr;19(2):139-144. doi: 10.1007/s40257-017-0321-x.
- Background: PubMed 18042334Tan JK, Tang J, Fung K, Gupta AK, Thomas DR, Sapra S, Lynde C, Poulin Y, Gulliver W, Sebaldt RJ. Development and validation of a comprehensive acne severity scale. J Cutan Med Surg. 2007 Nov-Dec;11(6):211-6. doi: 10.2310/7750.2007.00037.
- Background: PubMed 15764049Zhang JZ, Li LF, Tu YT, Zheng J. A successful maintenance approach in inflammatory acne with adapalene gel 0.1% after an initial treatment in combination with clindamycin topical solution 1% or after monotherapy with clindamycin topical solution 1%. J Dermatolog Treat. 2004 Dec;15(6):372-8. doi: 10.1080/09546630410021702.
- Background: PubMed 16702497Thiboutot DM, Shalita AR, Yamauchi PS, Dawson C, Kerrouche N, Arsonnaud S, Kang S. Adapalene gel, 0.1%, as maintenance therapy for acne vulgaris: a randomized, controlled, investigator-blind follow-up of a recent combination study. Arch Dermatol. 2006 May;142(5):597-602. doi: 10.1001/archderm.142.5.597.
- Background: PubMed 17567301Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007 Jul;21(6):747-53. doi: 10.1111/j.1468-3083.2007.02190.x.
- Background: PubMed 29549588Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.
- Background: PubMed 27272079Bhatia N, Bhatt V, Martin G, Pillai R. Two Randomized, Double-Blind, Split-Face Studies to Compare the Irritation Potential of Two Topical Acne Fixed Combinations Over a 21-Day Treatment Period. J Drugs Dermatol. 2016 Jun 1;15(6):721-6.
- Background: PubMed 26293170Chularojanamontri 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.
- Background: PubMed 29705755Chen X, Wang S, Yang M, Li L. Chemical peels for acne vulgaris: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 28;8(4):e019607. doi: 10.1136/bmjopen-2017-019607.
- Background: PubMed 22384983Matsunaga K, Leow YH, Chan R, Kerrouche N, Paliargues F. Adjunctive usage of a non-comedogenic moisturizer with adapalene gel 0.1% improves local tolerance: a randomized, investigator-blinded, split-face study in healthy Asian subjects. J Dermatolog Treat. 2013 Aug;24(4):278-82. doi: 10.3109/09546634.2012.661037. Epub 2012 Mar 4.
- Derived from this study: PubMed 33150170Kulthanan K, Trakanwittayarak S, Tuchinda P, Chularojanamontri L, Limphoka P, Varothai S. A Double-Blinded, Randomized, Vehicle-Controlled Study of the Efficacy of Moisturizer Containing Licochalcone A, Decanediol, L-Carnitine, and Salicylic Acid for Prevention of Acne Relapse in Asian Population. Biomed Res Int. 2020 Oct 16;2020:2857812. doi: 10.1155/2020/2857812. eCollection 2020.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanokvalai Kulthanan, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizer with active ingredients in people with Acne Vulgaris and Acne, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of acne lesion count of moisturizer containing the active ingredients of licochalcone A, decanediol, L-carnitine, and salicylic acid (time frame: 12th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002024, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.