Acne VulgarisPhase 4NCT05536193
Topical Metformin Emulgel VS Salicylic Acid Peeling in Treatment of Acne Vulgaris
A Phase 4 study testing Topical Metformin Emulgel and salicylic acid and Insulin- Like growth factor (ILGF-1) in people with Acne Vulgaris, run by Assiut University.
Trial summary
Acne Vulgaris (AV ) is a common skin disorder worldwide, affecting all ages and races, considered as a long term chronic inflammatory disease of the skin.It affects nearly 85% of adolescents and about 30% of adults which is known as post- adolescent acne that often occurs in individuals aged 25 years or older… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Topical Metformin Emulgel and salicylic acid and Insulin- Like growth factor (ILGF-1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2022to 10 Sep 2023
- Phase
- Phase 4
- 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
- Both males and females will be included.
- Patients older than 18 years of age.
- Patients with mild and moderate AV.
- Patients with Fitzpatrick skin type III, IV and V.
Who cannot join
- Severe acne.
- Patients under treatment with contraceptive pills or received any kinds of systemic or topical acne medication in the last 2 months (isotretinoin, antibiotics, topical products) or corticosteroid, lithium, growth hormone, systemic metformin, vitamin B12, whey proteins, and estrogenic-progestogens.
- History of hypertrophic/keloid scar formation.
- Pregnancy and lactation.
- Recurrent herpes infection.
- Subjects with diseases that affect IGF-1 levels such as diabetes, metabolic syndrome, and acromegaly.
- Conditions that affect liver or thyroid function, celiac disease and inflammatory bowel diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Topical Metformin Emulgel Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: A Split Face Study
Acne Vulgaris (AV ) is a common skin disorder worldwide, affecting all ages and races, considered as a long term chronic inflammatory disease of the skin.It affects nearly 85% of adolescents and about 30% of adults which is known as post- adolescent acne that often occurs in individuals aged 25 years or older particularly women.
Acne lesions, which may be papules, pustules, or nodules commonly affecting face, chest and back therefore acne patients may suffer from emotional distress due to its chronicity and potential outcomes which include physical scars and persistent hyperpigmentation.
Read more
The pathophysiology of AV involves four factors: abnormal follicular keratinization, hyperseborrhea, Cutibacterium acnes proliferation in the pilosebaceous unit and inflammatory mediators released into the skin.
Diet is considered to be one of the main factors influencing the induction and aggravation of acne, though this is still debatable. Previous researches have focused on glycemic load, and hyperinsulinemia which lead to an increase in the concentration of insulin-like growth factor (IGF-1), which has been reported to affect androgen metabolism and lipogenesis Additionally, IGF-1 has been shown to upregulate inflammatory cytokines. A correlation between the severity of acne and the level of serum IGF-1 has also been reported. Previous clinical studies showed that a low glycemic diet can decrease both the size of the sebaceous gland and the number of inflammatory lesions
Read the detailed description
Several treatment modalities have been used to treat AV. Topical therapies include antibiotics, azelaic acid, benzoyl peroxide, and retinoids. Systemic treatments include antibiotics, hormonal therapy, and isotretinoin in addition to physical modalities as chemical peeling .
Chemical peeling is a safe, efficacious, and cost-effective procedure for treating various skin disorders and for enhancing cosmetic appearance. The principle of peeling involves controlled chemical injury to the skin in order to promote it to rejuvenate, leading to smoothening of the skin and improvement of its surface texture .
As patients become more concerned about the risks and side-effects of acne medications such as antibiotics and isotretinoin, other options are needed .
Metformin is an oral antihyperglycemic agent often used to treat overweight type 2 diabetic patients. It decreases hepatic glucose output and increases glucose utilization by muscles and adipocytes by increasing insulin sensitivity .
Notably, metformin has been shown to suppress the mammalian target of rapamycin complex (mTORC1) activity . mTORC, also known as the mechanistic target of rapamycin, is a central cell growth regulating kinase that forms large molecular complexes in all eukaryotic cells. Rapamycin is an mTORC1-specific inhibitor, which complexes with the FK506-binding 12 kDa protein (FKBP12). Rapamycin analogs have been used clinically to treat a number of human diseases, including cancer. A wide range of both extra- and intracellular signals, including growth factors, nutrient status and stress conditions, have been shown to regulate mTORC1 to control cell growth .
Hence, it is plausible that metformin through inhibition of mTORC1 improves acne as AV is one of the mechanistic target of rapamycin complex 1 (mTORC1)-driven diseases. Moreover, metformin has been suggested for the treatment of other insulin resistant-related skin disorders such as hirsutism, hidradenitis suppurativa, and acanthosis nigricans .
In order to get a benefit from the anti-inflammatory effect of metformin on the skin, the best option is to enhance its dermal effects, therefore, its side effects will be less through the topical administration route .
Actually, by applying a topical form of this drug on acne spots, mTORC1 over activation in skin cells can be inhibited which leads to disappearance of acne spots .
Salicylic acid (SA) is a safe and efficacious peeling agent for a number of dermatological and cosmetic problems, including acne vulgaris .
SA peels soften the stratum corneum and cause skin shedding by loosening the intracellular matrix and corneocyte connections which can lead to an improvement in non-inflammatory comedones . Also, SA inhibits the arachidonic acid cascade leading to a decrease in inflammatory lesions .
In our study, we chose the emulgel formulation as a topical metformin form to increase the efficacy and absorption in treatment of AV. Emulgel used will be optimized for biocompatibility, consistency and chemical compatibility with metformin.
- Conditions
- Acne Vulgaris
- Being tested
- Topical Metformin Emulgel and salicylic acid, Insulin- Like growth factor (ILGF-1)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Metformin Emulgel and salicylic acidDrug
Combination Product: Topical metformin emulgel topical metformin emulgel will be used on the left side of the face twice daily (home use).
Procedure/Surgery: Salicylic acid Patients will have salicylic acid 30% peeling on the right side of the face as a peeling session every two weeks. Sessions will be done by well trained physician.
Other Names:
- 2-hydroxybenzoic acid
Insulin- Like growth factor (ILGF-1)Diagnostic test
3 ml blood for serum sample for estimation of Insulin- Like growth factor (ILGF-1) by ELISA kit will be taken from every patient before and after use of topical metformin.
| Study group | Role | What they receive |
|---|---|---|
| Topical Metformin Emulgel and salicylic acid | Experimental | Not described Receives: Drug: Topical Metformin Emulgel and salicylic acid; Diagnostic Test: Insulin- Like growth factor (ILGF-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the medications
by counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment.
Measured: 12 weeks
Evaluate effect of topical metformin on decreasing serum concentration of insulin-like growth factor 1 (IGF-1)
Evaluate effect of topical metformin on decreasing serum concentration of insulin-like growth factor 1 (IGF-1) by serum sample that will be taken from every patient before and after use of topical metformin.
Measured: 12 weeks
Secondary outcomes (2)
Assessment of tolerability
by interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus).
Measured: 12 weeks
Assessment of patient satisfaction
by quartile grading system
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 posted10 Sep 2022
- Study start10 Sep 2022 (estimated)
- Primary completion10 Sep 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will use salicylic acid 30% peeling on the right side of the face and topical metformin emulgel on the left side
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Ahmed Elminshawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536193
- Sponsor's protocol ID
- TMEVSSA
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012 Oct 15;86(8):734-40.
PubMed 23062156Han XD, Oon HH, Goh CL. Epidemiology of post-adolescence acne and adolescence acne in Singapore: a 10-year retrospective and comparative study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1790-1793. doi: 10.1111/jdv.13743. Epub 2016 Jul 12.
PubMed 27400809Hazarika N, Archana M. The Psychosocial Impact of Acne Vulgaris. Indian J Dermatol. 2016 Sep-Oct;61(5):515-20. doi: 10.4103/0019-5154.190102.
PubMed 27688440Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.
PubMed 21880356Kim H, Moon SY, Sohn MY, Lee WJ. Insulin-Like Growth Factor-1 Increases the Expression of Inflammatory Biomarkers and Sebum Production in Cultured Sebocytes. Ann Dermatol. 2017 Feb;29(1):20-25. doi: 10.5021/ad.2017.29.1.20. Epub 2017 Feb 3.
PubMed 28223742Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
PubMed 22678562Fox L, Csongradi C, Aucamp M, du Plessis J, Gerber M. Treatment Modalities for Acne. Molecules. 2016 Aug 13;21(8):1063. doi: 10.3390/molecules21081063.
PubMed 27529209Rendon MI, Berson DS, Cohen JL, Roberts WE, Starker I, Wang B. Evidence and considerations in the application of chemical peels in skin disorders and aesthetic resurfacing. J Clin Aesthet Dermatol. 2010 Jul;3(7):32-43.
PubMed 20725555Badr D, Kurban M, Abbas O. Metformin in dermatology: an overview. J Eur Acad Dermatol Venereol. 2013 Nov;27(11):1329-35. doi: 10.1111/jdv.12116. Epub 2013 Feb 26.
PubMed 23437788Yuan HX, Guan KL. Structural insights of mTOR complex 1. Cell Res. 2016 Mar;26(3):267-8. doi: 10.1038/cr.2016.10. Epub 2016 Jan 22.
PubMed 26794870Arif T. Salicylic acid as a peeling agent: a comprehensive review. Clin Cosmet Investig Dermatol. 2015 Aug 26;8:455-61. doi: 10.2147/CCID.S84765. eCollection 2015.
PubMed 26347269Lin AN, Nakatsui T. Salicylic acid revisited. Int J Dermatol. 1998 May;37(5):335-42. doi: 10.1046/j.1365-4362.1998.00452.x. No abstract available.
PubMed 9620477Lee HS, Kim IH. Salicylic acid peels for the treatment of acne vulgaris in Asian patients. Dermatol Surg. 2003 Dec;29(12):1196-9; discussion 1199. doi: 10.1111/j.1524-4725.2003.29384.x.
PubMed 14725662
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Metformin Emulgel Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: A Split Face Study
- ClinicalTrials.gov ID
- NCT05536193
- Acronym / sponsor ID
- TMEVSSA
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (estimated)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 10 Sep 2022 (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.
Acne Vulgaris (AV ) is a common skin disorder worldwide, affecting all ages and races, considered as a long term chronic inflammatory disease of the skin.It affects nearly 85% of adolescents and about 30% of adults which is known as post- adolescent acne that often occurs in individuals aged 25 years or older particularly women.
Acne lesions, which may be papules, pustules, or nodules commonly affecting face, chest and back therefore acne patients may suffer from emotional distress due to its chronicity and potential outcomes which include physical scars and persistent hyperpigmentation.
The pathophysiology of AV involves four factors: abnormal follicular keratinization, hyperseborrhea, Cutibacterium acnes proliferation in the pilosebaceous unit and inflammatory mediators released into the skin.
Diet is considered to be one of the main factors influencing the induction and aggravation of acne, though this is still debatable. Previous researches have focused on glycemic load, and hyperinsulinemia which lead to an increase in the concentration of insulin-like growth factor (IGF-1), which has been reported to affect androgen metabolism and lipogenesis Additionally, IGF-1 has been shown to upregulate inflammatory cytokines. A correlation between the severity of acne and the level of serum IGF-1 has also been reported. Previous clinical studies showed that a low glycemic diet can decrease both the size of the sebaceous gland and the number of inflammatory lesions
Detailed description
Several treatment modalities have been used to treat AV. Topical therapies include antibiotics, azelaic acid, benzoyl peroxide, and retinoids. Systemic treatments include antibiotics, hormonal therapy, and isotretinoin in addition to physical modalities as chemical peeling .
Chemical peeling is a safe, efficacious, and cost-effective procedure for treating various skin disorders and for enhancing cosmetic appearance. The principle of peeling involves controlled chemical injury to the skin in order to promote it to rejuvenate, leading to smoothening of the skin and improvement of its surface texture .
As patients become more concerned about the risks and side-effects of acne medications such as antibiotics and isotretinoin, other options are needed .
Metformin is an oral antihyperglycemic agent often used to treat overweight type 2 diabetic patients. It decreases hepatic glucose output and increases glucose utilization by muscles and adipocytes by increasing insulin sensitivity .
Notably, metformin has been shown to suppress the mammalian target of rapamycin complex (mTORC1) activity . mTORC, also known as the mechanistic target of rapamycin, is a central cell growth regulating kinase that forms large molecular complexes in all eukaryotic cells. Rapamycin is an mTORC1-specific inhibitor, which complexes with the FK506-binding 12 kDa protein (FKBP12). Rapamycin analogs have been used clinically to treat a number of human diseases, including cancer. A wide range of both extra- and intracellular signals, including growth factors, nutrient status and stress conditions, have been shown to regulate mTORC1 to control cell growth .
Hence, it is plausible that metformin through inhibition of mTORC1 improves acne as AV is one of the mechanistic target of rapamycin complex 1 (mTORC1)-driven diseases. Moreover, metformin has been suggested for the treatment of other insulin resistant-related skin disorders such as hirsutism, hidradenitis suppurativa, and acanthosis nigricans .
In order to get a benefit from the anti-inflammatory effect of metformin on the skin, the best option is to enhance its dermal effects, therefore, its side effects will be less through the topical administration route .
Actually, by applying a topical form of this drug on acne spots, mTORC1 over activation in skin cells can be inhibited which leads to disappearance of acne spots .
Salicylic acid (SA) is a safe and efficacious peeling agent for a number of dermatological and cosmetic problems, including acne vulgaris .
SA peels soften the stratum corneum and cause skin shedding by loosening the intracellular matrix and corneocyte connections which can lead to an improvement in non-inflammatory comedones . Also, SA inhibits the arachidonic acid cascade leading to a decrease in inflammatory lesions .
In our study, we chose the emulgel formulation as a topical metformin form to increase the efficacy and absorption in treatment of AV. Emulgel used will be optimized for biocompatibility, consistency and chemical compatibility with metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will use salicylic acid 30% peeling on the right side of the face and topical metformin emulgel on the left side
| Arm | Type | Receives |
|---|---|---|
| Topical Metformin Emulgel and salicylic acid | Experimental | Drug: Topical Metformin Emulgel and salicylic acid, Diagnostic Test: Insulin- Like growth factor (ILGF-1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both males and females will be included.
- Patients older than 18 years of age.
- Patients with mild and moderate AV.
- Patients with Fitzpatrick skin type III, IV and V.
Key exclusion criteria (7 listed)
- Severe acne.
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 |
|---|---|---|
| Topical Metformin Emulgel and salicylic acidCombination Product: Topical metformin emulgel topical metformin emulgel will be used on the left side of the face twice daily (home use). Procedure/Surgery: Salicylic acid Patients will have salicylic acid 30% peeling on the right side of the face as a peeling session every two weeks. Sessions will be done by well trained physician. Other Names: • 2-hydroxybenzoic acid | Drug | Topical Metformin Emulgel and salicylic acid |
| Insulin- Like growth factor (ILGF-1)3 ml blood for serum sample for estimation of Insulin- Like growth factor (ILGF-1) by ELISA kit will be taken from every patient before and after use of topical metformin. | Diagnostic test | Topical Metformin Emulgel and salicylic acid |
Primary outcome
Efficacy of the medications
Time frame: 12 weeks
by counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment.
Evaluate effect of topical metformin on decreasing serum concentration of insulin-like growth factor 1 (IGF-1)
Time frame: 12 weeks
Evaluate effect of topical metformin on decreasing serum concentration of insulin-like growth factor 1 (IGF-1) by serum sample that will be taken from every patient before and after use of topical metformin.
2 secondary outcomes
Assessment of tolerability
Time frame: 12 weeks
Assessment of patient satisfaction
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 23062156Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012 Oct 15;86(8):734-40.
- Background: PubMed 27400809Han XD, Oon HH, Goh CL. Epidemiology of post-adolescence acne and adolescence acne in Singapore: a 10-year retrospective and comparative study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1790-1793. doi: 10.1111/jdv.13743. Epub 2016 Jul 12.
- Background: PubMed 27688440Hazarika N, Archana M. The Psychosocial Impact of Acne Vulgaris. Indian J Dermatol. 2016 Sep-Oct;61(5):515-20. doi: 10.4103/0019-5154.190102.
- Background: PubMed 21880356Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.
- Background: PubMed 28223742Kim H, Moon SY, Sohn MY, Lee WJ. Insulin-Like Growth Factor-1 Increases the Expression of Inflammatory Biomarkers and Sebum Production in Cultured Sebocytes. Ann Dermatol. 2017 Feb;29(1):20-25. doi: 10.5021/ad.2017.29.1.20. Epub 2017 Feb 3.
- Background: PubMed 22678562Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
- Background: PubMed 27529209Fox L, Csongradi C, Aucamp M, du Plessis J, Gerber M. Treatment Modalities for Acne. Molecules. 2016 Aug 13;21(8):1063. doi: 10.3390/molecules21081063.
- Background: PubMed 20725555Rendon MI, Berson DS, Cohen JL, Roberts WE, Starker I, Wang B. Evidence and considerations in the application of chemical peels in skin disorders and aesthetic resurfacing. J Clin Aesthet Dermatol. 2010 Jul;3(7):32-43.
- Background: PubMed 23437788Badr D, Kurban M, Abbas O. Metformin in dermatology: an overview. J Eur Acad Dermatol Venereol. 2013 Nov;27(11):1329-35. doi: 10.1111/jdv.12116. Epub 2013 Feb 26.
- Background: PubMed 26794870Yuan HX, Guan KL. Structural insights of mTOR complex 1. Cell Res. 2016 Mar;26(3):267-8. doi: 10.1038/cr.2016.10. Epub 2016 Jan 22.
- Background: PubMed 26347269Arif T. Salicylic acid as a peeling agent: a comprehensive review. Clin Cosmet Investig Dermatol. 2015 Aug 26;8:455-61. doi: 10.2147/CCID.S84765. eCollection 2015.
- Background: PubMed 9620477Lin AN, Nakatsui T. Salicylic acid revisited. Int J Dermatol. 1998 May;37(5):335-42. doi: 10.1046/j.1365-4362.1998.00452.x. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Metformin Emulgel and salicylic acid and Insulin- Like growth factor (ILGF-1) in people with Acne Vulgaris, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ensaf M Abdel-Maguid, Professor (01005521529, ensaf.khalil@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the medications (time frame: 12 weeks). The study lists 2 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 NCT05536193, which also lists 13 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 10 Sep 2022.