Topical Metformin Emulgel VS Salicylic Acid Peeling in Treatment of Acne Vulgaris

NCT05536193 | Unknown Phase 4

• 1 other identifier: TMEVSSA
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Efficacy of the medications

  by counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment.

  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.

  12 weeks

Secondary Outcomes (2)

• Assessment of tolerability

  12 weeks

• Assessment of patient satisfaction

  12 weeks

Study Arms (1)

Topical Metformin Emulgel and salicylic acid

EXPERIMENTAL

Drug: Topical Metformin Emulgel and salicylic acid; Diagnostic Test: Insulin- Like growth factor (ILGF-1)

Interventions

Topical Metformin Emulgel and salicylic acid DRUG

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

Topical Metformin Emulgel and salicylic 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.

Topical Metformin Emulgel and salicylic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012 Oct 15;86(8):734-40.

  PMID: 23062156 BACKGROUND

• Han 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.

  PMID: 27400809 BACKGROUND

• Hazarika 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.

  PMID: 27688440 BACKGROUND

• Williams 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.

  PMID: 21880356 BACKGROUND

• Kim 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.

  PMID: 28223742 BACKGROUND

• Kwon 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.

  PMID: 22678562 BACKGROUND

• Fox 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.

  PMID: 27529209 BACKGROUND

• Rendon 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.

  PMID: 20725555 BACKGROUND

• Badr 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.

  PMID: 23437788 BACKGROUND

• Yuan 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.

  PMID: 26794870 BACKGROUND

• Arif 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.

  PMID: 26347269 BACKGROUND

• Lin 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.

  PMID: 9620477 BACKGROUND

• Lee 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.

  PMID: 14725662 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

Ensaf M Abdel-Maguid, Professor

CONTACT

01005521529; ensaf.khalil@med.aun.edu.eg

Heba H Sayed, PHD

CONTACT

01002866919; hebahasan16888@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will use salicylic acid 30% peeling on the right side of the face and topical metformin emulgel on the left side

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 10, 2022
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share