NCT05536193

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

Status unknown Phase 4 Last updated 10 September 2022

What this trial tests

Phase 4 trial testing Topical Metformin Emulgel and salicylic acid in Acne Vulgaris in 34 participants. Status unknown.

Timeline

10 September 2022

Primary endpoint
10 September 2023

10 September 2023

Quick facts

Lead sponsor	Assiut University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	10 September 2022
Primary completion	10 September 2023
Estimated completion	10 September 2023

Drugs / interventions tested

• Topical Metformin Emulgel and salicylic acid — full drug profile →
• Insulin- Like growth factor (ILGF-1)

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Assiut University

Who can join

18 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nanoemulgel: A Novel Nano Carrier as a Tool for Topical Drug Delivery.
   Donthi MR, Donthi MR, Munnangi SR, Krishna KV, et al · · 2023 · cited 73× · PMID 36678794 · DOI 10.3390/pharmaceutics15010164