NCT05017454

Brief Summary

the aim of this study is to assess the efficacy and safety of sodium valproate-loaded nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with topical steroids

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

August 14, 2021

Last Update Submit

June 9, 2023

Conditions

Alopecia Areata

Keywords

sodium valproate-loaded nanospanlastictopical steroidsbeta cateninalopecia areata

Outcome Measures

Primary Outcomes (1)

  • - Treatment success

    defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.

    6 months

Secondary Outcomes (8)

  • molecular Assessment of treatment success rate of SV-loaded nanospanlastics in the treatment of mild to moderate patchy AA in comparison to conventional therapy with topical steroids

    3 months

  • Dermoscopic evaluation of hair regrowth

    3 months

  • Patient global assessment of improvement

    3 months

  • Clinical satisfaction of each patient

    3 months

  • Subjective assessment of any encountered adverse effects

    3 months

  • +3 more secondary outcomes

Study Arms (2)

sodium valproate group

EXPERIMENTAL

Group 1 will be treated with the optimized sodium valproate-loaded nanospanlastic dispersion, twice daily on the affected areas of the scalp for 3 months

Drug: the optimized sodium valproate-loaded nanospanlastic dispersion

topical steroid group

ACTIVE COMPARATOR

Group 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Drug: mometasone furoate lotion

Interventions

the optimized sodium valproate-loaded nanospanlastic dispersionDRUG

participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months

sodium valproate group
mometasone furoate lotionDRUG

participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

topical steroid group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate patchy alopecia areata, which is defined as less than 50% involvement of the entire scalp
  • Age above 12 years.
  • Both genders.
  • Patients with patchy alopecia areata, with 2 patches or more

You may not qualify if:

  • Patients having single patch alopecia areata (at least 2 patches are required, as one patch will be left untreated to exclude the possibility of spontaneous remission)
  • Affection of more than 50% of the scalp area
  • Patients with alopecia totalis or universalis
  • Patients with ophiasis
  • Age: Less than 12 years old.
  • Pregnant or lactating females
  • Patients with history of or existing scalp skin diseases, infections or skin cancer
  • Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases) and immune-compromised patients
  • Patients with concomitant autoimmune diseases as suspected by history or confirmed by previous investigations
  • Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis.
  • Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Hospital, Dermatology Department

Cairo, Egypt

Location

Related Publications (1)

  • Mogawer RM, Fawzy MM, Mourad A, Ahmed H, Nasr M, Nour ZA, Hafez V. Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study. Arch Dermatol Res. 2024 Jan 3;316(2):64. doi: 10.1007/s00403-023-02785-1.

    PMID: 38170256DERIVED

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • heba ahmed, Msc in dermatolo

    Kasralainy Hospital, Faculty of Medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 23, 2021

Study Start

May 1, 2021

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)