A Novel Formulation of Sildenafil-loaded Nanocarriers for Treatment of Alopecia Areata

NCT06527729 | Completed Early Phase 1

• 1 other identifier: Sildenafil-loaded nanocarriers
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Alopecia areata (AA) is a common cause of nonscarring alopecia that occurs in a patchy, confluent, or diffuse pattern. Many theories were implicated in pathogenesis of AA, such as an autoimmune lymphocytic attack of the hair, genetic basis, and environmental factors. Clinically, AA presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area with the scalp being the most commonly affected site . Dermoscopy is a noninvasive technique for the clinical diagnosis of many skin diseases. Dermoscopy is now considered as a valuable tool in diagnosis of variable skin lesions. Scalp dermoscopy (Trichoscopy) does not only facilitate diagnosis of hair disorders but also give clues about disease stage and progression. The most common trichoscopic features of AA are yellow dots, micro-exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs. Trichoscopic characteristics have a clinical significance in AA for diagnosis and prognosis. The treatment of alopecia areata involves promotion of hair growth (for instance with topical minoxidil application), immunosuppression (intralesional or systemic steroid therapy, phototherapy) or immunomodulation (anthralin, dinitrochlorobenzene, diphenylcyclopropenone, squaric acid dibutylester).Unfortunately, there is currently no cure for this chronic disease, and despite the presence of a wide variety of therapeutic options, none is universally proven to induce and/or sustain remission. Development of new drugs and formulations is urgently needed Sildenafil, a phosphodiesterase 5 (PDE5) inhibitor, is known to increase the intracellular level of cyclic guanosine monophosphate (cGMP), which causes vasodilation. Sildenafil was first approved in 1998 for erectile dysfunction, but since then additional uses for the drug have been found. A previous study demonstrated the significant therapeutic potential of sildenafil on hair growth and proposed its potential use in treatment of alopecia. It has been shown that it enhances proliferation of human dermal papilla cells (hDPCs) and up-regulates the mRNA expression of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF), which are responsible for hair growth. Additionally, sildenafil up-regulates the levels of phosphorylated ERK and accelerates anagen induction by stimulating perifollicular vessel formation after topical application in mice.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• The efficacy of topical sildenafil-loaded liposomes formulation compared with topical minoxidil therapy for the treatment of patchy alopecia areata

  the comparison of serial photographs of the lesions to the baseline ones. Severity of Alopecia Tool (SALT) score was calculated, at baseline, 4 weeks and 8 weeks and the average percentage of hair re-growth was determined using the SALT scoring system for hair re-growth and graded as A0: no change or further hair loss, A1: 1-24% hair re-growth, A2: 25-49% hair re-growth, A3: 50-74% hair regrowth, A4: 75-99% hair re-growth, and A5: 100% hair re-growth

  8 weeks

• Dermoscopic asessment

  Dermoscopic examination was carried out before treatment and at 4 and 8 weeks, using the handheld dermoscope (DermLite DL4, 3Gen, Inc., San Juan Capistrano, CA 92675). Baseline and post-therapy digital photographs of dermoscopic fields were taken using an iPhone 6S smartphone camera. Dermoscopic features of AA were evaluated including yellow dots, black dots, broken hair, exclamation-mark hairs, short vellus hair and regrowing hair. Two dermoscopic fields were examined; one from the center and the other at 3 o'clock position of the alopecia patch. Trichoscopic parameters in each field were evaluated and quantified.

  8 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Topical 5% minoxidil gel was applied twice daily for a period of 8 weeks.

Drug: minoxidil gel

Group 2

EXPERIMENTAL

Topical 1% sildenafil-loaded liposomes was applied twice daily for a period of 8 weeks.

Drug: sildenafil-loaded liposomes

Interventions

sildenafil-loaded liposomes DRUG

Topical 1% sildenafil-loaded liposomes was applied twice daily for a period of 8 weeks over patchy alopecia areata of the scalp.

Group 2

minoxidil gel DRUG

Topical 5% minoxidil gel was applied twice daily for a period of 8 weeks.

Group 1

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a clinical and dermoscopic diagnosis of patchy alopecia areata of the scalp.

You may not qualify if:

• Alopecia totalis/universalis.
• Ophiasis.
• Those with systemic and/or other dermatological diseases.
• Those receiving treatment for a lopecia areata in the previous 3 months.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut university

Asyut, Egypt

Location

Related Publications (1)

• Owis AI, El-Hawary MS, El Amir D, Refaat H, Alaaeldin E, Aly OM, Elrehany MA, Kamel MS. Flavonoids of Salvadora persica L. (meswak) and its liposomal formulation as a potential inhibitor of SARS-CoV-2. RSC Adv. 2021 Apr 12;11(22):13537-13544. doi: 10.1039/d1ra00142f. eCollection 2021 Apr 7.

  PMID: 35423847 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eman Fathy, MD

  Assiut university, Faculty of Medicine, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Model Details: Patients were randomly assigned to use either topical 5% minoxidil gel or topical 1% sildenafil-loaded liposomes twice daily for a period of 8 weeks.

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)