Acne VulgarisPhase 4NCT04490967
Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris
A Phase 4 study testing Silymarin and Salicylic acid in people with Acne Vulgaris, run by Assiut University.
Trial summary
Acne vulgaris is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. 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?
- Silymarin and Salicylic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Dec 2021
- 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
- Patients older than 18 years of age.
- Patients with mild and moderate acne vulgaris.
- Patients with Fitzpatrick skin type III, IV and V.
Who cannot join
- Severe acne.
- Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
- History of hypertrophic/keloid scar formation.
- Pregnancy.
- Recurrent herpes infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study
Acne vulgaris is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. Acne vulgaris is an extremely common condition with a lifetime prevalence of approximately 85% and occurs mostly during adolescence.
Acne vulgaris leads to significant morbidity that is associated with residual scarring and psychological disturbances such as poor self-image, depression, and anxiety, which leads to a negative impact on quality of life.
Read more
The treatment of acne vulgaris is challenging and often chronic, with high rates of failure and numerous choices. Frequent evaluations (i.e., every 8-12 weeks) are important to enable appropriate monitoring, manage adverse effects, and evaluate for medication compliance.
Topical therapies are considered one of the mainstay treatments for patients with mild-to-moderate acne.
Read the detailed description
Chemical peeling is one of the most common cosmetic procedures in medical practice and has been used for decades. It is defined as the application of chemical agents, of variable strength, on the skin that results in controlled destruction of the epidermis and dermis. The induced exfoliation is followed by dermal and epidermal regeneration from adjacent epithelium and skin adnexa, which results in improved surface texture and appearance of the skin. This is a simple and cost-effective procedure with several dermatological applications.
Salicylic acid is a 2-hydroxybenzoic acid used for superficial peeling due to its strong keratolytic and comedolytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum. These chemical properties explain its popularity and success in acne patients. Also, it has well-documented anti-inflammatory properties.
Silymarin is a standardized extract from S. marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, Silymarin is utilized in dermatological and cosmetic preparations for its antioxidant effect anti-inflammatory and immunomodulatory properties.
Various studies have been created to evaluate the efficacy of Silymarin in UV protection, prevention against skin cancer and against actinic keratosis.
Silymarin showed efficacy the treatment of Rosacea, Melasma, Vitiligo, Psoriasis, atopic dermatitis and contact dermatitis . Other studies showed that Silymarin has anti aging properties and potential action for wound healing .
- Conditions
- Acne Vulgaris
- Being tested
- Silymarin, 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.
SilymarinCombination product
Also called Silybin, Silybum, Marian thistle.
Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).
Salicylic acidProcedure or surgery
Also called 2-hydroxybenzoic 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.
| Study group | Role | What they receive |
|---|---|---|
| Silymarin and salicylic acid | Experimental | There will be one group of patients, that will use salicylic acid peeling on the right side of the face and topical Silymarin cream on the left side Receives: Combination Product: Silymarin; Procedure: Salicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment
Measured: 12 weeks
assessment of tolerability: interviewing the patients
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
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 posted29 Jul 2020
- Study startApr 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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 Silymarin 1.4% cream on the left side.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Ahmed Makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490967
- Sponsor's protocol ID
- SMVSA
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.
PubMed 23210645Ramos-e-Silva M, Ramos-e-Silva S, Carneiro S. Acne in women. Br J Dermatol. 2015 Jul;172 Suppl 1:20-6. doi: 10.1111/bjd.13638.
PubMed 25597414Kamangar F, Shinkai K. Acne in the adult female patient: a practical approach. Int J Dermatol. 2012 Oct;51(10):1162-74. doi: 10.1111/j.1365-4632.2012.05519.x.
PubMed 22994662Nast A, Dreno B, Bettoli V, Degitz K, Erdmann R, Finlay AY, Ganceviciene R, Haedersdal M, Layton A, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Rzany B, Sammain A, Simonart T, Veien NK, Zivkovic MV, Zouboulis CC, Gollnick H; European Dermatology Forum. European evidence-based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol. 2012 Feb;26 Suppl 1:1-29. doi: 10.1111/j.1468-3083.2011.04374.x. No abstract available.
PubMed 22356611Al-Talib H, Al-Khateeb A, Hameed A, Murugaiah C. Efficacy and safety of superficial chemical peeling in treatment of active acne vulgaris. An Bras Dermatol. 2017 Mar-Apr;92(2):212-216. doi: 10.1590/abd1806-4841.20175273.
PubMed 28538881Rendon 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 20725555Clark E, Scerri L. Superficial and medium-depth chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):209-18. doi: 10.1016/j.clindermatol.2007.09.015.
PubMed 18472062Arif 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 26347269Lee 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 14725662Handog EB, Datuin MS, Singzon IA. Chemical peels for acne and acne scars in asians: evidence based review. J Cutan Aesthet Surg. 2012 Oct;5(4):239-46. doi: 10.4103/0974-2077.104911.
PubMed 23378705Vaid M, Katiyar SK. Molecular mechanisms of inhibition of photocarcinogenesis by silymarin, a phytochemical from milk thistle (Silybum marianum L. Gaertn.) (Review). Int J Oncol. 2010 May;36(5):1053-60. doi: 10.3892/ijo_00000586.
PubMed 20372777Surai PF. Silymarin as a Natural Antioxidant: An Overview of the Current Evidence and Perspectives. Antioxidants (Basel). 2015 Mar 20;4(1):204-47. doi: 10.3390/antiox4010204.
PubMed 26785346Katiyar SK, Mantena SK, Meeran SM. Silymarin protects epidermal keratinocytes from ultraviolet radiation-induced apoptosis and DNA damage by nucleotide excision repair mechanism. PLoS One. 2011;6(6):e21410. doi: 10.1371/journal.pone.0021410. Epub 2011 Jun 22.
PubMed 21731736Meeran SM, Katiyar S, Elmets CA, Katiyar SK. Silymarin inhibits UV radiation-induced immunosuppression through augmentation of interleukin-12 in mice. Mol Cancer Ther. 2006 Jul;5(7):1660-8. doi: 10.1158/1535-7163.MCT-06-0095.
PubMed 16891451Katiyar SK, Meleth S, Sharma SD. Silymarin, a flavonoid from milk thistle (Silybum marianum L.), inhibits UV-induced oxidative stress through targeting infiltrating CD11b+ cells in mouse skin. Photochem Photobiol. 2008 Mar-Apr;84(2):266-71. doi: 10.1111/j.1751-1097.2007.00241.x. Epub 2007 Nov 28.
PubMed 18221354
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study
- ClinicalTrials.gov ID
- NCT04490967
- Acronym / sponsor ID
- SMVSA
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jul 2020 (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 is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. Acne vulgaris is an extremely common condition with a lifetime prevalence of approximately 85% and occurs mostly during adolescence.
Acne vulgaris leads to significant morbidity that is associated with residual scarring and psychological disturbances such as poor self-image, depression, and anxiety, which leads to a negative impact on quality of life.
The treatment of acne vulgaris is challenging and often chronic, with high rates of failure and numerous choices. Frequent evaluations (i.e., every 8-12 weeks) are important to enable appropriate monitoring, manage adverse effects, and evaluate for medication compliance.
Topical therapies are considered one of the mainstay treatments for patients with mild-to-moderate acne.
Detailed description
Chemical peeling is one of the most common cosmetic procedures in medical practice and has been used for decades. It is defined as the application of chemical agents, of variable strength, on the skin that results in controlled destruction of the epidermis and dermis. The induced exfoliation is followed by dermal and epidermal regeneration from adjacent epithelium and skin adnexa, which results in improved surface texture and appearance of the skin. This is a simple and cost-effective procedure with several dermatological applications.
Salicylic acid is a 2-hydroxybenzoic acid used for superficial peeling due to its strong keratolytic and comedolytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum. These chemical properties explain its popularity and success in acne patients. Also, it has well-documented anti-inflammatory properties.
Silymarin is a standardized extract from S. marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, Silymarin is utilized in dermatological and cosmetic preparations for its antioxidant effect anti-inflammatory and immunomodulatory properties.
Various studies have been created to evaluate the efficacy of Silymarin in UV protection, prevention against skin cancer and against actinic keratosis.
Silymarin showed efficacy the treatment of Rosacea, Melasma, Vitiligo, Psoriasis, atopic dermatitis and contact dermatitis . Other studies showed that Silymarin has anti aging properties and potential action for wound healing .
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 Silymarin 1.4% cream on the left side.
| Arm | Type | Receives |
|---|---|---|
| Silymarin and salicylic acid | Experimental | Combination Product: Silymarin, Procedure: Salicylic acidThere will be one group of patients, that will use salicylic acid peeling on the right side of the face and topical Silymarin cream on the left side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years of age.
- Patients with mild and moderate acne vulgaris.
- Patients with Fitzpatrick skin type III, IV and V.
Key exclusion criteria (5 listed)
- Severe acne.
- Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
- History of hypertrophic/keloid scar formation.
- Pregnancy.
- Recurrent herpes infection.
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 |
|---|---|---|
| SilymarinAlso: Silybin, Silybum, Marian thistle.Silymarin 1.4% cream will be used on the left side of the face twice daily (home use). | Combination product | Silymarin and salicylic acid |
| Salicylic acidAlso: 2-hydroxybenzoic acidPatients 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. | Procedure or surgery | Silymarin and salicylic acid |
Primary outcome
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
Time frame: 12 weeks
counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment
assessment of tolerability: interviewing the patients
Time frame: 12 weeks
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 23210645Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149.
- Background: PubMed 25597414Ramos-e-Silva M, Ramos-e-Silva S, Carneiro S. Acne in women. Br J Dermatol. 2015 Jul;172 Suppl 1:20-6. doi: 10.1111/bjd.13638.
- Background: PubMed 22994662Kamangar F, Shinkai K. Acne in the adult female patient: a practical approach. Int J Dermatol. 2012 Oct;51(10):1162-74. doi: 10.1111/j.1365-4632.2012.05519.x.
- Background: PubMed 22356611Nast A, Dreno B, Bettoli V, Degitz K, Erdmann R, Finlay AY, Ganceviciene R, Haedersdal M, Layton A, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Rzany B, Sammain A, Simonart T, Veien NK, Zivkovic MV, Zouboulis CC, Gollnick H; European Dermatology Forum. European evidence-based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol. 2012 Feb;26 Suppl 1:1-29. doi: 10.1111/j.1468-3083.2011.04374.x. No abstract available.
- Background: PubMed 28538881Al-Talib H, Al-Khateeb A, Hameed A, Murugaiah C. Efficacy and safety of superficial chemical peeling in treatment of active acne vulgaris. An Bras Dermatol. 2017 Mar-Apr;92(2):212-216. doi: 10.1590/abd1806-4841.20175273.
- 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 18472062Clark E, Scerri L. Superficial and medium-depth chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):209-18. doi: 10.1016/j.clindermatol.2007.09.015.
- 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 14725662Lee 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.
- Background: PubMed 23378705Handog EB, Datuin MS, Singzon IA. Chemical peels for acne and acne scars in asians: evidence based review. J Cutan Aesthet Surg. 2012 Oct;5(4):239-46. doi: 10.4103/0974-2077.104911.
- Background: PubMed 20372777Vaid M, Katiyar SK. Molecular mechanisms of inhibition of photocarcinogenesis by silymarin, a phytochemical from milk thistle (Silybum marianum L. Gaertn.) (Review). Int J Oncol. 2010 May;36(5):1053-60. doi: 10.3892/ijo_00000586.
- Background: PubMed 26785346Surai PF. Silymarin as a Natural Antioxidant: An Overview of the Current Evidence and Perspectives. Antioxidants (Basel). 2015 Mar 20;4(1):204-47. doi: 10.3390/antiox4010204.
- 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 Silymarin and Salicylic acid 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 3 inclusion and 5 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 12 Mar 2021. 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 D A Ahmed, Professor (+20 100 567 7229, daliaattallah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions (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 NCT04490967, which also lists 31 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 12 Mar 2021.