Topical Metformin Versus Topical Ketotifen in Melasma Treatment
Launched by ASSIUT UNIVERSITY · Apr 16, 2025
Trial Information
Current as of May 20, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different treatments for melasma, a skin condition that causes dark patches on the face. The researchers want to compare a new version of topical metformin, which is made using tiny particles, to topical ketotifen, also made with tiny particles. They will test these treatments alone and in combination with a procedure called micro-needling, which involves using small needles to help improve the skin. The study will involve 102 women who have been diagnosed with bilateral melasma, meaning they have patches on both sides of their face.
To participate in this trial, women must be at least 18 years old and have a clinical diagnosis of melasma. However, pregnant or nursing women, those using hormonal birth control, or anyone who has had certain skin treatments in the last three months cannot join. Participants can expect to have their skin treated with either of the creams on one side of their face, while the other side receives the other treatment. It's important for potential participants to understand that they will need to be able to give informed consent and have realistic expectations about the outcomes of the treatments. This study is not yet recruiting, so there will be more information available soon for those interested in participating.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Female adults of 18 years and above with bilateral melasma .
- • Clinical diagnosis of melasma.
- • Mental capacity to give informed consent.
- Exclusion Criteria:
- • Pregnant or nursing women.
- • Current use of hormonal birth control medication or any hormonal therapy.
- • Current or previous treatment by depigmenting agents within 3 months
- • History of laser or MN to the face within 3 months of study enrollment.
- • Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids.
- • Photosensitivity.
- • Patients with unrealistic expectations.
About Assiut University
Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Radwa Bakr, Assistant professor
Study Director
Assiot university
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported