Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients
Open accessAbstract
Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05).
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A liposomal-based formulation of RA (monotherapy) was successfully tested in patients with facial acne and refractory hematological malignancies in a phase II clinical trial.
“For example, a liposomal-based formulation of RA (monotherapy) was successfully tested in patients with facial acne71 and refractory hematological malignancies in a phase II clinical trial70.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [71]
The higher efficacy of the ATRA-loaded liposomal formulation was attributed to enhanced penetration of RA across the stratum corneum.
“The higher efficacy of the ATRA-loaded liposomal formulation was attributed to enhanced penetration of RA across the stratum corneum.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [71]
Patients with facial acne treated with the liposomal formulation showed higher lesion improvements than with conventional formulations.
“Patients with facial acne treated with the liposomal formulation showed higher lesion improvements than with conventional formulations.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [71]
The advantages of RA formulations have been demonstrated in preclinical (in all applications described in this review) and clinical trials (cancer and skin applications).
“The advantages of RA formulations have been demonstrated in preclinical (in all applications described in this review) and clinical trials (cancer and skin applications)71,129.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [71]
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Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine
Ferreira, R., Napoli, J., Enver, T., Bernardino, L., & Ferreira, L. (2020) · Nature Communications · doi:10.1038/s41467-020-18042-2 · Cited by 138 · see citing works
- Authors
- Rahman, S. A., Abdelmalak, N. S., Badawi, A., Elbayoumy, T., Sabry, N., & El Ramly, A.
- Affiliations
- National Organization for Drug Control and Research (EG)
- Department of Pharmaceutics, Faculty of Pharmacy,
- Department of Clinical Pharmacy, Faculty of Pharmacy, and
- Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt
- Corresponding author
- Abdelmalak, Nevine Shawky
- Venue
- Drug Delivery
- Publisher
- Informa UK Limited
- Published
- 2015-05-25
- Volume
- 23
- Issue
- 4
- Pages
- 1184-1193
- ISSN
- 1071-7544 (ISSN-L)
- 1521-0464
- OpenAlex
- W1833457070
- Cited by
- 64
- References
- 52
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 9 · 2023: 4 · 2022: 10 · 2021: 10 · 2020: 7 · 2019: 4 · 2018: 3 · 2017: 1 · 2016: 3
- FWCI
- 1.29
- Type
- journal article
- Language
- en
- Update notices
- correction (2015-11-11)
- Open access
- bronze
- doi.org
- Locations
- Drug Delivery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advancements in Transdermal Drug Delivery
- Health Sciences › Medicine › Dermatology › Acne and Rosacea Treatments and Effects
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Keywords
- all-trans retinoic acid, liposomal gel, acne, topical retinoids, skin irritation, dicetyl phosphate, vesicle size, drug incorporation efficiency, drug release, factorial design, film hydration method, Carbopol gel
- MeSH terms
- Acne Vulgaris, Administration, Topical, Adult, Chemistry, Pharmaceutical, Cholesterol, Female, Gels, Humans, Liposomes, Male, Phospholipids, Organophosphates, Tretinoin, Skin Irritancy Tests, Drug Liberation
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