Facial HyperpigmentationNCT03926845
Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation
A study testing Isobutylamido-thiazolyl-resorcinol Cream 0.2% in people with Facial Hyperpigmentation, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial summary
Facial hyperpigmentation is a common skin issue that can cause embarrassment and affect the quality of life in majority of people. The investigators are conducting a research to study an efficacy and tolerability of Isobutylamido-thiazolyl-resorcinol 0.2% in lightening of the facial hyperpigmentation in comparison to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Hyperpigmentation
- What is being tested?
- Isobutylamido-thiazolyl-resorcinol Cream 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 29 Apr 2019to 31 Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are Thai adults age 18 years old and above .
- Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports.
- Subjects must be able to attend monthly sessions in the period of 12 weeks session.
- Subjects must refrain from using other whitening cream such as hydroquinone, azelaic acid, kojic acid, arbutin, glycolic acid or any other creams which whiten the skin including chemical peel or whitening pills such as Tranexamic acid at least 1 month before the trial.
- Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial.
- Subjects who can apply sun screen with UVA and UVB protection that has a minimum of SPF30 daily.
Who cannot join
- Subjects who have conditions such as Lichen planus pigmentosus, Pigmented contact dermatitis, Photosensitivity, Ashy dermatosis, Dermal melanosis, e.g. Nevus of Hori, Nevus of Ota, Dermal melanocyte hamartoma
- Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis
- Subjects with a congenital or serious disease with unpredictable symptoms such as Cirrhosis, cardiovascular diseases, Neurological diseases, gastrointestinal disease, Reproductive system diseases, Cancer and Psychiatric diseases.
- Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue)
- Female subjects with pregnancy and breastfeeding.
- Subjects who are allergic to chemical compound in the cream such as Alcohol denat, Phenoxyethanol or fragrance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation, A Randomized Double-blind and Vehicle-Controlled Study
Facial hyperpigmentation is a common skin issue that can cause embarrassment and affect the quality of life in majority of people. The investigators are conducting a research to study an efficacy and tolerability of Isobutylamido-thiazolyl-resorcinol 0.2% in lightening of the facial hyperpigmentation in comparison to vehicle intervention in 4, 8 and 12-week period. The ultimate goal is to provide the best cosmetic cream to improve the quality of life of people who suffer from facial hyperpigmentation.
Read the detailed description
Facial hyperpigmentation is a skin issue that occurs frequently in people with darker skin types. Studies show that the prevalence of facial hyperpigmentation is related to ethnicity and is accounted for up to 40%of the total population. The pathogenesis of facial hyperpigmentation is still unclear, but several factors seem to contribute such as ultraviolet radiation, female hormones, and genetics, which increase melanin production in the skin cells, specifically the epidermal melanocyte, and dermal melanophage. Hyperpigmentation can be embarrassing and affect the quality of life in the pertained individuals.
Tyrosinase enzyme plays a key element in melanin production which causes dark areas. In 2018, several studies have reported a new cosmetic product using Isobutylamido-thiazolyl-resorcinol (Beiersdorf AG, Hamburg, Germany) in facial hyperpigmentation. In vitro studies found that in melanocyte culture, Isobutylamido-thiazolyl-resorcinol inhibit melanin production. Studies discovered that Isobutylamido-thiazolyl-resorcinol 0.2% can reduce facial hyperpigmentation within 4 weeks. Hyperpigmentation begin to fade away within 12 weeks of daily application.
The objective is to study efficacy and tolerability of a cosmetic formulation with Isobutylamido-thiazolyl-resorcinol 0.2% compared to its vehicle in facial hyperpigmentation after 4, 8 and 12-week.
This is a randomized double-blind and vehicle-controlled study. Two hundred subjects both male and female 18 years or older with facial hyperpigmentation are recruited in the study. The study was performed at the Institute of Dermatology, Bangkok, Thailand. Subjects agree to attend monthly sessions every 4 weeks for 12 weeks.
- Conditions
- Facial Hyperpigmentation
- Being tested
- Isobutylamido-thiazolyl-resorcinol Cream 0.2%, Vehicle
- Keywords
- Isobutylamido-thiazolyl-resorcinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobutylamido-thiazolyl-resorcinol Cream 0.2%Other
Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks.
VehicleOther
Each bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Isobutylamido-thiazolyl-resorcinol Cream 0.2% | Active comparator | The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol. Receives: Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2% |
| Vehicle | Placebo comparator | The cream contains no active ingredients. Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit.
Each visit, photos are taken on all patients by VISIA-CR system camera on 3 positions of the face, straight and 37* on both sides with standard unfiltered and cross polarized lens. Each time the photos are filed and the colors are analyzed in order to be compared the changes between visits.
Measured: 12 weeks
Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Measured: 12 weeks
Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Measured: 12 weeks
Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit.
Visual self-grading by patients from 1 to 10 by 1 is the least and 10 is the most in the criteria of evenness, spots and skin clarity
Measured: 12 weeks
Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit.
All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start29 Apr 2019
- Primary completion30 Nov 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Facial HyperpigmentationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, vehicle controlled, double-blind study and is performed at the Institute of Dermatology. Subjects are randomized into 2 groups by a computer prior to the start of the study - group 1 receives Isobutylamido-thiazolyl-resorcinol 0.2% cream and group 2 receives vehicle cream for 12 weeks. Both Study products have to be applied twice daily.Total of 4 clinical sessions are carried out in order to evaluate Isobutylamido-thiazolyl-resorcinol 0.2% efficacy and tolerability at week 4, 8 and 12. Subjects and investigators are blinded about allocation. The appearance of the vehicle formulation was similar to the verum formulation and could not be distinguished neither by patients nor by the investigator.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Collaborators
- Beiersdorf (Thailand) Co., Ltd.
- Responsible party
- Principal investigator, Chinmanat Lekhavat, Institute of Dermatology, Thailand
- Investigators
- Chinmanat Lekhavat, MD, Principal investigator, Institute of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926845
- Sponsor's protocol ID
- 013/2562
- Status last verified
- Mar 2022
- First submitted
- 22 Apr 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Briganti S, Camera E, Picardo M. Chemical and instrumental approaches to treat hyperpigmentation. Pigment Cell Res. 2003 Apr;16(2):101-10. doi: 10.1034/j.1600-0749.2003.00029.x.
PubMed 12622786Rossi AM, Perez MI. Treatment of hyperpigmentation. Facial Plast Surg Clin North Am. 2011 May;19(2):313-24. doi: 10.1016/j.fsc.2011.05.010.
PubMed 21763992Ortonne JP, Pandya AG, Lui H, Hexsel D. Treatment of solar lentigines. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S262-71. doi: 10.1016/j.jaad.2005.12.043.
PubMed 16631967Mann T, Gerwat W, Batzer J, Eggers K, Scherner C, Wenck H, Stab F, Hearing VJ, Rohm KH, Kolbe L. Inhibition of Human Tyrosinase Requires Molecular Motifs Distinctively Different from Mushroom Tyrosinase. J Invest Dermatol. 2018 Jul;138(7):1601-1608. doi: 10.1016/j.jid.2018.01.019. Epub 2018 Feb 7.
PubMed 29427586Lacz NL, Vafaie J, Kihiczak NI, Schwartz RA. Postinflammatory hyperpigmentation: a common but troubling condition. Int J Dermatol. 2004 May;43(5):362-5. doi: 10.1111/j.1365-4632.2004.02267.x. No abstract available.
PubMed 15117368Espin JC, Varon R, Fenoll LG, Gilabert MA, Garcia-Ruiz PA, Tudela J, Garcia-Canovas F. Kinetic characterization of the substrate specificity and mechanism of mushroom tyrosinase. Eur J Biochem. 2000 Mar;267(5):1270-9. doi: 10.1046/j.1432-1327.2000.01013.x.
PubMed 10691963Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156.
PubMed 1402005Lekhavat C, Rojanamatin J, Suphannaphong M, Kolbe L. Efficacy and Tolerability of 0.2% Thiamidol Cream for Facial Hyperpigmentation: A Randomized, Double-Blind, and Vehicle-Controlled Study. Dermatol Ther (Heidelb). 2026 Mar;16(3):1551-1565. doi: 10.1007/s13555-025-01649-y. Epub 2026 Jan 21.
PubMed 41566113
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation, A Randomized Double-blind and Vehicle-Controlled Study
- ClinicalTrials.gov ID
- NCT03926845
- Acronym / sponsor ID
- 013/2562
- Conditions
- Facial Hyperpigmentation
- Keywords
- Isobutylamido-thiazolyl-resorcinol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Collaborators
- Beiersdorf (Thailand) Co., Ltd.
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 25 Apr 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.
Facial hyperpigmentation is a common skin issue that can cause embarrassment and affect the quality of life in majority of people. The investigators are conducting a research to study an efficacy and tolerability of Isobutylamido-thiazolyl-resorcinol 0.2% in lightening of the facial hyperpigmentation in comparison to vehicle intervention in 4, 8 and 12-week period. The ultimate goal is to provide the best cosmetic cream to improve the quality of life of people who suffer from facial hyperpigmentation.
Detailed description
Facial hyperpigmentation is a skin issue that occurs frequently in people with darker skin types. Studies show that the prevalence of facial hyperpigmentation is related to ethnicity and is accounted for up to 40%of the total population. The pathogenesis of facial hyperpigmentation is still unclear, but several factors seem to contribute such as ultraviolet radiation, female hormones, and genetics, which increase melanin production in the skin cells, specifically the epidermal melanocyte, and dermal melanophage. Hyperpigmentation can be embarrassing and affect the quality of life in the pertained individuals.
Tyrosinase enzyme plays a key element in melanin production which causes dark areas. In 2018, several studies have reported a new cosmetic product using Isobutylamido-thiazolyl-resorcinol (Beiersdorf AG, Hamburg, Germany) in facial hyperpigmentation. In vitro studies found that in melanocyte culture, Isobutylamido-thiazolyl-resorcinol inhibit melanin production. Studies discovered that Isobutylamido-thiazolyl-resorcinol 0.2% can reduce facial hyperpigmentation within 4 weeks. Hyperpigmentation begin to fade away within 12 weeks of daily application.
The objective is to study efficacy and tolerability of a cosmetic formulation with Isobutylamido-thiazolyl-resorcinol 0.2% compared to its vehicle in facial hyperpigmentation after 4, 8 and 12-week.
This is a randomized double-blind and vehicle-controlled study. Two hundred subjects both male and female 18 years or older with facial hyperpigmentation are recruited in the study. The study was performed at the Institute of Dermatology, Bangkok, Thailand. Subjects agree to attend monthly sessions every 4 weeks for 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, vehicle controlled, double-blind study and is performed at the Institute of Dermatology. Subjects are randomized into 2 groups by a computer prior to the start of the study - group 1 receives Isobutylamido-thiazolyl-resorcinol 0.2% cream and group 2 receives vehicle cream for 12 weeks. Both Study products have to be applied twice daily.Total of 4 clinical sessions are carried out in order to evaluate Isobutylamido-thiazolyl-resorcinol 0.2% efficacy and tolerability at week 4, 8 and 12. Subjects and investigators are blinded about allocation. The appearance of the vehicle formulation was similar to the verum formulation and could not be distinguished neither by patients nor by the investigator.
| Arm | Type | Receives |
|---|---|---|
| Isobutylamido-thiazolyl-resorcinol Cream 0.2% | Active comparator | Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2%The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol. |
| Vehicle | Placebo comparator | Other: VehicleThe cream contains no active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects are Thai adults age 18 years old and above .
- Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports.
- Subjects must be able to attend monthly sessions in the period of 12 weeks session.
- Subjects must refrain from using other whitening cream such as hydroquinone, azelaic acid, kojic acid, arbutin, glycolic acid or any other creams which whiten the skin including chemical peel or whitening pills such as Tranexamic acid at least 1 month before the trial.
- Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial.
Key exclusion criteria (6 listed)
- Subjects who have conditions such as Lichen planus pigmentosus, Pigmented contact dermatitis, Photosensitivity, Ashy dermatosis, Dermal melanosis, e.g. Nevus of Hori, Nevus of Ota, Dermal melanocyte hamartoma
- Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis
- Subjects with a congenital or serious disease with unpredictable symptoms such as Cirrhosis, cardiovascular diseases, Neurological diseases, gastrointestinal disease, Reproductive system diseases, Cancer and Psychiatric diseases.
- Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue)
- Female subjects with pregnancy and breastfeeding.
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 |
|---|---|---|
| Isobutylamido-thiazolyl-resorcinol Cream 0.2%Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks. | Other | Isobutylamido-thiazolyl-resorcinol Cream 0.2% |
| VehicleEach bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks. | Other | Vehicle |
Primary outcome
Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit.
Time frame: 12 weeks
Each visit, photos are taken on all patients by VISIA-CR system camera on 3 positions of the face, straight and 37* on both sides with standard unfiltered and cross polarized lens. Each time the photos are filed and the colors are analyzed in order to be compared the changes between visits.
Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Time frame: 12 weeks
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Time frame: 12 weeks
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit.
Time frame: 12 weeks
Visual self-grading by patients from 1 to 10 by 1 is the least and 10 is the most in the criteria of evenness, spots and skin clarity
Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit.
Time frame: 12 weeks
All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.
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 6 Apr 2022.
- Background: PubMed 12622786Briganti S, Camera E, Picardo M. Chemical and instrumental approaches to treat hyperpigmentation. Pigment Cell Res. 2003 Apr;16(2):101-10. doi: 10.1034/j.1600-0749.2003.00029.x.
- Background: PubMed 21763992Rossi AM, Perez MI. Treatment of hyperpigmentation. Facial Plast Surg Clin North Am. 2011 May;19(2):313-24. doi: 10.1016/j.fsc.2011.05.010.
- Background: PubMed 16631967Ortonne JP, Pandya AG, Lui H, Hexsel D. Treatment of solar lentigines. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S262-71. doi: 10.1016/j.jaad.2005.12.043.
- Background: PubMed 29427586Mann T, Gerwat W, Batzer J, Eggers K, Scherner C, Wenck H, Stab F, Hearing VJ, Rohm KH, Kolbe L. Inhibition of Human Tyrosinase Requires Molecular Motifs Distinctively Different from Mushroom Tyrosinase. J Invest Dermatol. 2018 Jul;138(7):1601-1608. doi: 10.1016/j.jid.2018.01.019. Epub 2018 Feb 7.
- Background: PubMed 15117368Lacz NL, Vafaie J, Kihiczak NI, Schwartz RA. Postinflammatory hyperpigmentation: a common but troubling condition. Int J Dermatol. 2004 May;43(5):362-5. doi: 10.1111/j.1365-4632.2004.02267.x. No abstract available.
- Background: PubMed 10691963Espin JC, Varon R, Fenoll LG, Gilabert MA, Garcia-Ruiz PA, Tudela J, Garcia-Canovas F. Kinetic characterization of the substrate specificity and mechanism of mushroom tyrosinase. Eur J Biochem. 2000 Mar;267(5):1270-9. doi: 10.1046/j.1432-1327.2000.01013.x.
- Background: PubMed 1402005Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156.
- Derived from this study: PubMed 41566113Lekhavat C, Rojanamatin J, Suphannaphong M, Kolbe L. Efficacy and Tolerability of 0.2% Thiamidol Cream for Facial Hyperpigmentation: A Randomized, Double-Blind, and Vehicle-Controlled Study. Dermatol Ther (Heidelb). 2026 Mar;16(3):1551-1565. doi: 10.1007/s13555-025-01649-y. Epub 2026 Jan 21.
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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.
Chinmanat Lekhavat, MD principal investigator
Institute of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isobutylamido-thiazolyl-resorcinol Cream 0.2% in people with Facial Hyperpigmentation, run by Institute of Dermatology, Thailand 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 6 inclusion and 6 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 6 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit. (time frame: 12 weeks). The study lists 5 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 NCT03926845, which also lists 8 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 6 Apr 2022.