- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433907
Efficacy of an Antioxidant Moisturizing Serum for Mild to Moderate Seborrheic Dermatitis (Pilot RCT)
March 4, 2026 updated by: Institute of Dermatology, Thailand
A Prospective, Randomized, Split-Face Pilot Study Comparing the Efficacy of the Institute of Dermatology's Antioxidant Moisturizing Serum in Mild to Moderate Seborrheic Dermatitis
This is a 4-week comparison study between the intervention and control sides of the face.
Purposive sampling to recruit 13 patients with seborrheic dermatitis will be conducted in this study.
The study will start after researcher has been granted the Ethic Committee Approval.
The process of subject recruitment and clinical data collection will take place at the Outpatient Department (OPD) while photograph taking and skin measurement will take place at Laser Center and Bioengineering Department, respectively.
All bioengineering instruments will be operated under the climate controlled environment; i.e, at temperature 20+/-2 degree Celsius and 50+/-2 % of relative humidity.
A subject must get acclimatized to the ambient atmosphere for at least 30 minutes.
The clinical data, skin barrier function, the quality of life, subject's satisfaction scale will be collected at the first day (D0, as baseline) and 4th week after finishing the test product (Wk4).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Veng Ang Lok, Medical Doctor
- Phone Number: +66839392488, +85598988089
- Email: lokvengang@gmail.com
Study Contact Backup
- Name: Walaiorn Pratchyapruit, Medical Doctor
- Phone Number: +66 958784022
- Email: Itesatuk@yahoo.com
Study Locations
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Recruiting
- Institute of dermatology
-
Contact:
- Institute of Dermatology
- Phone Number: +6623545222-1524
- Email: iodresearch@gmail.com
-
Principal Investigator:
- Veng Ang Lok, Medical Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Age: ≥ 18 years old
- Gender: Male and Female
- Patient who never uses or has stopped using topical corticosteroids/calcineurin inhibitor or other topical treatments exerting anti-inflammatory action (on the face) more than 2 weeks before entering this clinical trials.
- Patient who does not use cosmetic containing any oxidants or others that exert anti-oxidant effect(s). If there is any, one must refrain from using them more than 2 weeks before entering this clinical trials.
Exclusion Criteria
- Patients with known cases of underlying HIV/AIDS, neurological condition e.g., Parkinson's disease.
- Patient associated with any autoimmune diseases and other skin diseases
- Patient takes any forms of oral immunotherapy more than 2 months up to the first day of clinical trials.
- Patients continuously use of topical corticosteroids or other anti-inflammatory medicines on regular basis up to the first day of clinical trial.
- Patient who refuses to stop using cosmetic(s) containing anti-oxidants or those exert anti-oxidant effect(s).
- Patient who is allergic to the test product or one of its ingredients.
- Pregnancy or nursing woman
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
Antioxidant Moisturizing Serum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SEDASI score
Time Frame: 1 year
|
To compare clinical improvement as assessed by SEDASI score, between the intervention and control sides of the face in subjects with mild to moderate seborrheic dermatitis after 4 weeks of application of Institute of Dermatology's antioxidant moisturizing serum.
This study uses split-face design.
Due to the split-face study design and use of the SEDASI score, the same scoring scales were applied for extension (area, 0-6), presentation pattern (0-3), erythema (0-3), and scaling (0-3).
The nasal area was excluded because split application to the nose is impractical.
The original severity classification was therefore divided by two to obtain a hemiface-specific severity classification.
Note: As the nasal area represents approximately 1% of the facial surface and the study compares the two sides of the face, this modification does not affect the primary study objective.
The total score may range from 0 (no Seborrheic Dermatitis) to 30 (Seborrheic Dermatitis of the worst possible degree).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Barrier function
Time Frame: 4 weeks
|
To evaluate skin barrier function, as measured by transepidermal water loss (TEWL) and skin hydration, and surface lipid after 4 weeks of using IOD's antioxidant moisturizing serum. To evaluate facial skin appearance-including glossiness, desquamation, roughness, smoothness, wrinkles, elasticity, and redness-after 4 weeks of using IOD's antioxidant moisturizing serum. |
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Veng Ang Lok, Medical Doctor, Rangsit University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Yan H, Zhang S, Sun W, Li J, Xu J, Bi Y, Wu X, Song B. A bibliometric and visual analysis of the research status and hotspots of seborrheic dermatitis based on web of science. Skin Res Technol. 2024 Sep;30(9):e70048. doi: 10.1111/srt.70048.
- Woolhiser E, Keime N, Patel A, Weber I, Adelman M, Dellavalle RP. Nutrition, Obesity, and Seborrheic Dermatitis: Systematic Review. JMIR Dermatol. 2024 Aug 5;7:e50143. doi: 10.2196/50143.
- Wikramanayake TC, Borda LJ, Miteva M, Paus R. Seborrheic dermatitis-Looking beyond Malassezia. Exp Dermatol. 2019 Sep;28(9):991-1001. doi: 10.1111/exd.14006. Epub 2019 Aug 19.
- Trusler AR, Clark AK, Sivamani RK, Shi VY. The Endocannabinoid System and Its Role in Eczematous Dermatoses. Dermatitis. 2017 Jan/Feb;28(1):22-32. doi: 10.1097/DER.0000000000000257.
- Tosti A, Schwartz JR. Role of scalp health in achieving optimal hair growth and retention. Int J Cosmet Sci. 2021 Nov;43 Suppl 1:S1-S8. doi: 10.1111/ics.12708.
- Szepietowski JC, Reich A, Wesolowska-Szepietowska E, Baran E; National Quality of Life in Dermatology Group. Quality of life in patients suffering from seborrheic dermatitis: influence of age, gender and education level. Mycoses. 2009 Jul;52(4):357-63. doi: 10.1111/j.1439-0507.2008.01624.x. Epub 2008 Sep 12.
- Schwartz JR, Messenger AG, Tosti A, Todd G, Hordinsky M, Hay RJ, Wang X, Zachariae C, Kerr KM, Henry JP, Rust RC, Robinson MK. A comprehensive pathophysiology of dandruff and seborrheic dermatitis - towards a more precise definition of scalp health. Acta Derm Venereol. 2013 Mar 27;93(2):131-7. doi: 10.2340/00015555-1382.
- Sanders MGH, Pardo LM, Ginger RS, Kiefte-de Jong JC, Nijsten T. Association between Diet and Seborrheic Dermatitis: A Cross-Sectional Study. J Invest Dermatol. 2019 Jan;139(1):108-114. doi: 10.1016/j.jid.2018.07.027. Epub 2018 Aug 18.
- Rusic D, Ivic M, Slugan A, Leskur D, Modun D, Durdov T, Vukovic D, Bukic J, Bozic J, Seselja Perisin A. Pilot Study on the Effects of a Cosmetic Serum Containing Niacinamide, Postbiotics and Peptides on Facial Skin in Healthy Participants: A Randomized Controlled Trial. Life (Basel). 2024 Dec 18;14(12):1677. doi: 10.3390/life14121677.
- Rousel J, Nadaban A, Saghari M, Pagan L, Zhuparris A, Theelen B, Gambrah T, van der Wall HEC, Vreeken RJ, Feiss GL, Niemeyer-van der Kolk T, Burggraaf J, van Doorn MBA, Bouwstra JA, Rissmann R. Lesional skin of seborrheic dermatitis patients is characterized by skin barrier dysfunction and correlating alterations in the stratum corneum ceramide composition. Exp Dermatol. 2024 Jan;33(1):e14952. doi: 10.1111/exd.14952. Epub 2023 Nov 16.
- Ezerskaia A,Ras A,Bloemen P,Pereira SF,Urbach HP,Varghese B
- Ormel J,Jeronimus BF,Kotov R,Riese H,Bos EH,Hankin B,Rosmalen JGM,Oldehinkel AJ
- Campione E,Mazzilli S,Lanna C,Cosio T,Palumbo V,Cesaroni G,Lozzi F,Diluvio L,Bianchi L
- Pigatto PD, Diani M. Beneficial Effects of Antioxidant Furfuryl Palmitate in Non-pharmacologic Treatments (Prescription Emollient Devices, PEDs) for Atopic Dermatitis and Related Skin Disorders. Dermatol Ther (Heidelb). 2018 Sep;8(3):339-347. doi: 10.1007/s13555-018-0239-0. Epub 2018 May 22.
- Peyri J, Lleonart M; Grupo espanol del Estudio SEBDERM. [Clinical and therapeutic profile and quality of life of patients with seborrheic dermatitis]. Actas Dermosifiliogr. 2007 Sep;98(7):476-82. Spanish.
- Park M, Lee JS, Jung WH, Lee YW. pH-Dependent Expression, Stability, and Activity of Malassezia restricta MrLip5 Lipase. Ann Dermatol. 2020 Dec;32(6):473-480. doi: 10.5021/ad.2020.32.6.473. Epub 2020 Nov 11.
- Nam GW, Baek JH, Koh JS, Hwang JK. The seasonal variation in skin hydration, sebum, scaliness, brightness and elasticity in Korean females. Skin Res Technol. 2015 Feb;21(1):1-8. doi: 10.1111/srt.12145. Epub 2014 Feb 17.
- Nakai K, Tsuruta D. What Are Reactive Oxygen Species, Free Radicals, and Oxidative Stress in Skin Diseases? Int J Mol Sci. 2021 Oct 6;22(19):10799. doi: 10.3390/ijms221910799.
- Mittal M, Siddiqui MR, Tran K, Reddy SP, Malik AB. Reactive oxygen species in inflammation and tissue injury. Antioxid Redox Signal. 2014 Mar 1;20(7):1126-67. doi: 10.1089/ars.2012.5149. Epub 2013 Oct 22.
- Md Jaffri J. Reactive Oxygen Species and Antioxidant System in Selected Skin Disorders. Malays J Med Sci. 2023 Feb;30(1):7-20. doi: 10.21315/mjms2023.30.1.2. Epub 2023 Feb 28.
- Mastrolonardo M, Diaferio A, Logroscino G. Seborrheic dermatitis, increased sebum excretion, and Parkinson's disease: a survey of (im)possible links. Med Hypotheses. 2003 Jun;60(6):907-11. doi: 10.1016/s0306-9877(03)00094-x.
- Limongi D, Baldelli S, Checconi P, Marcocci ME, De Chiara G, Fraternale A, Magnani M, Ciriolo MR, Palamara AT. GSH-C4 Acts as Anti-inflammatory Drug in Different Models of Canonical and Cell Autonomous Inflammation Through NFkappaB Inhibition. Front Immunol. 2019 Feb 6;10:155. doi: 10.3389/fimmu.2019.00155. eCollection 2019.
- Leedle RA, Aust SD. The effect of glutathione on the vitamin E requirement for inhibition of liver microsomal lipid peroxidation. Lipids. 1990 May;25(5):241-5. doi: 10.1007/BF02544382.
- Has, C. (2018). Peeling Skin Disorders: A Paradigm for Skin Desquamation. The Journal of Investigative Dermatology, 138(8), 1689-1691. https://doi.org/10.1016/j.jid.2018.05.020
- Gupta AK, Bluhm R, Barlow JO, Fleischer AB Jr, Feldman SR. Prescribing practices for seborrheic dermatitis vary with the physician's specialty: implications for clinical practice. J Dermatolog Treat. 2004 Jul;15(4):208-13. doi: 10.1080/09546630410032430.
- Gül, A. İ., Karaaslan, Ö., & Çölgeçen, E. (2017). Personality traits and common psychiatric conditions in patients with seborrheic dermatitis. Archives of Clinical Psychiatry (São Paulo), 44(1), 6-9. https://doi.org/10.1590/0101-60830000000106
- Glueck, D. H. (2008). Sample Size Calculations in Clinical Research 2nd edition by CHOW, S.-C., SHAO, J., and WANG, H. Biometrics, 64(4), 1307-1308. https://doi.org/10.1111/j.1541-0420.2008.01138_10.x
- Galizia, G., Belloni Fortina, A., & Semenzato, A. (2024a). Seborrheic Dermatitis: From Microbiome and Skin Barrier Involvement to Emerging Approaches in Dermocosmetic Treatment. Cosmetics, 11(6), Article 6. https://doi.org/10.3390/cosmetics11060208
- Faergemann J. Management of seborrheic dermatitis and pityriasis versicolor. Am J Clin Dermatol. 2000 Mar-Apr;1(2):75-80. doi: 10.2165/00128071-200001020-00001.
- Faergemann J. Treatment of seborrhoeic dermatitis of the scalp with ketoconazole shampoo. A double-blind study. Acta Derm Venereol. 1990;70(2):171-2.
- English JC., S. A. (n.d.). An overview of medicated shampoos used in dandruff treatment. 2006.
- Emre S, Metin A, Demirseren DD, Akoglu G, Oztekin A, Neselioglu S, Erel O. The association of oxidative stress and disease activity in seborrheic dermatitis. Arch Dermatol Res. 2012 Nov;304(9):683-7. doi: 10.1007/s00403-012-1254-0. Epub 2012 Jun 15.
- Cheong WK, Yeung CK, Torsekar RG, Suh DH, Ungpakorn R, Widaty S, Azizan NZ, Gabriel MT, Tran HK, Chong WS, Shih IH, Dall'Oglio F, Micali G. Treatment of Seborrhoeic Dermatitis in Asia: A Consensus Guide. Skin Appendage Disord. 2016 May;1(4):187-96. doi: 10.1159/000444682. Epub 2016 Mar 23.
- Binder RL, Jonelis FJ. Seborrheic dermatitis: a newly reported side effect of neuroleptics. J Clin Psychiatry. 1984 Mar;45(3):125-6.
- Berk T, Scheinfeld N. Seborrheic dermatitis. P T. 2010 Jun;35(6):348-52.
- Baş, Y., Kalkan, G., Yıldız, M., Özuğuz, P., Seçkin, H. Y., Takcı, Z., & Songur, E. (2015). Depression, Anxiety Levels and Quality of Life in Patients with Seborrheic Dermatitis. Turkish Journal of Dermatology / Türk Dermatoloji Dergisi, 9(4), 181-185. https://doi.org/10.4274/tdd.2586
- Bae YS, Oh H, Rhee SG, Yoo YD. Regulation of reactive oxygen species generation in cell signaling. Mol Cells. 2011 Dec;32(6):491-509. doi: 10.1007/s10059-011-0276-3. Epub 2011 Dec 22.
- Araya M, Kulthanan K, Jiamton S. Clinical Characteristics and Quality of Life of Seborrheic Dermatitis Patients in a Tropical Country. Indian J Dermatol. 2015 Sep-Oct;60(5):519. doi: 10.4103/0019-5154.164410.
- A New Synthetic Endocannabinoid-as-Anti-Inflammaging-Cosmetic-Active-an-In-Vitro-Study-on-a-Reconstructed-Skin-Model. (n.d.). Retrieved March 16, 2025, from https://grfpublishers.com/article/view/MzA=/A-New-Synthetic-Endocannabinoid-as-Anti-Inflammaging-Cosmetic-Active-an-In-Vitro-Study-on-a-Reconstructed-Skin-Model
- Alshaebi M, Zahed L, Osaylan M, Sulaimani S, Albahlool A, Abduljabbar MH, Hariri J. Association Between Diet and Seborrheic Dermatitis: A Case-Control Study. Cureus. 2023 Nov 14;15(11):e48782. doi: 10.7759/cureus.48782. eCollection 2023 Nov.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 20, 2026
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
February 19, 2026
First Submitted That Met QC Criteria
February 19, 2026
First Posted (Actual)
February 25, 2026
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 4, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 026/2568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We are not allowed to share IPD without participants' permission in advance.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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