Moisturizer Containing Licochalcone A, Decanediol, L-carnitine and Salicylic Acid in Reducing Relapsing of Acne
NCT ID: NCT04002024
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-06-01
2020-05-01
Brief Summary
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Detailed Description
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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
1. Acne lesion count and severity according to IGA scale.
2. Bioengineering evaluation
* Stratum corneum hydration will be evaluated by Corneometer®
* Transepidermal water loss will be evaluated by Tewameter®
* Sebum will be evaluated by Sebumeter®
3. The assessment of skin dyspigmentation and skin radiance assessed by Visia® and Antera 3D®.
4. The skin tolerability (erythema, dryness, scaling, stinging/burning and pruritus)
5. Rating of satisfaction evaluted by VAS score.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo and Treatment Arm A
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.
Moisturizer with active ingredients
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
Placebo
Placebo: 1 fingertip unit to cover one side of the face twice a day
Treatment and Placebo Arm B
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.
Moisturizer with active ingredients
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
Placebo
Placebo: 1 fingertip unit to cover one side of the face twice a day
Interventions
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Moisturizer with active ingredients
Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
Placebo
Placebo: 1 fingertip unit to cover one side of the face twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
1. rare non-inflammatory lesions with no more than one small inflammatory lesion
2. mild severity defines as some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions)
3. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
4. moderate severity defines as up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
5. 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
Exclusion Criteria
2. Patients with active skin disease at face within 2 weeks prior to the study
3. Patients with an allergic to licochalcone A, decanediol, L-carnitine, or salicylic acid
4. Patients with severe and uncontrollable comorbidities
5. Pregnant or breastfeeding women
6. Patients with other types of acne apart from acne vulgaris
7. Patients with an allergic to oral doxycycline
18 Years
ALL
No
Sponsors
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Beiersdorf
UNKNOWN
Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Kanokvalai Kulthanan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Countries
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References
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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.
Tan 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.
Zhang 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.
Thiboutot 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.
Thielitz 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.
Dreno 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.
Bhatia 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.
Chularojanamontri 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.
Chen 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.
Matsunaga 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.
Kulthanan 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.
Other Identifiers
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Eucerine proacne
Identifier Type: -
Identifier Source: org_study_id
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