Alopecia AreataEarly Phase 1NCT05017454
Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids
A Early Phase 1 study testing the optimized sodium valproate-loaded nanospanlastic dispersion and mometasone furoate lotion in people with Alopecia Areata, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- the optimized sodium valproate-loaded nanospanlastic dispersion and mometasone furoate lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements
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
Read the detailed description
Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response.
keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal.
Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease.
Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil
- Conditions
- Alopecia Areata
- Being tested
- the optimized sodium valproate-loaded nanospanlastic dispersion, mometasone furoate lotion
- Keywords
- sodium valproate-loaded nanospanlastic, topical steroids, beta catenin, alopecia areata
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
mometasone furoate lotionDrug
participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: mometasone furoate lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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%.
Measured: 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
Assessment of expression of both beta-catenin and Axin2 in lesional scalp of patients with patchy AA before and after treatment with sodium valproate-loaded nanospanlastics, in comparison to conventional therapy with topical steroids
Measured: 3 months
Dermoscopic evaluation of hair regrowth
This evaluation will determine the number of dystrophic hairs in the patch area at baseline to be compared after the end of treatment. Markers for dystrophic hairs include exclamation-mark hairs, black dots, yellow dots and pigtail regrowing hair. The percentage of dystrophic hairs will be evaluated on a four-point scale: 3, > 50%; 2, 30-50%; 1, 1-29%; 0, no dystrophic hairs
Measured: 3 months
Patient global assessment of improvement
Patient global assessment of improvement will be evaluated at the end of study, and will be scored as the following; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Measured: 3 months
Clinical satisfaction of each patient
Clinical satisfaction of each patient will be made using a 10-point visual analogue scale (VAS, 0-10; the 0 level was defined as "Not satisfied at all," while a level of 10 was defined as "completely satisfied")
Measured: 3 months
Subjective assessment of any encountered adverse effects
Subjective assessment of any encountered adverse effects (burning, itching) will also be performed. This will be determined on a four-point scale: 3, strong sensation; 2, moderate sensation; 1, mild sensation; 0, no itching or burning sensation
Measured: 3 months
Patient satisfaction regarding characteristics of the used topical treatment
Patient satisfaction regarding characteristics of the used topical treatment, for example (texture, spreadability, hair matting, odour). This will be evaluated on a 3-point scale; 0=unsatisfied, 1=moderately satisfied, 2=extremely satisfied
Measured: 3 months
Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index (DLQI) will be evaluated at baseline and at the end of therapy, using a validated DLQI questionaire
Measured: 3 months
Assessment of relapse
Patients who achieved 100% reduction in baseline SALT after 3 months of treatment (end of therapy) were followed up for additional 3 months (end of study) to monitor any relapses.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 May 2021
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
- Investigators
- heba ahmed, Msc in dermatolo, Principal investigator, Kasralainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017454
- Sponsor's protocol ID
- 264199200
- Status last verified
- Jun 2023
- First submitted
- 14 Aug 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38170256
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements
- ClinicalTrials.gov ID
- NCT05017454
- Acronym / sponsor ID
- 264199200
- Conditions
- Alopecia Areata
- Keywords
- sodium valproate-loaded nanospanlastic, topical steroids, beta catenin, alopecia areata
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response.
keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal.
Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease.
Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium valproate group | Experimental | Drug: the optimized sodium valproate-loaded nanospanlastic dispersionGroup 1 will be treated with the optimized sodium valproate-loaded nanospanlastic dispersion, twice daily on the affected areas of the scalp for 3 months |
| topical steroid group | Active comparator | Drug: mometasone furoate lotionGroup 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the optimized sodium valproate-loaded nanospanlastic dispersionparticipants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months | Drug | sodium valproate group |
| mometasone furoate lotionparticipants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months | Drug | topical steroid group |
Primary outcome
- Treatment success
Time frame: 6 months
defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.
8 secondary outcomes
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
Time frame: 3 months
Dermoscopic evaluation of hair regrowth
Time frame: 3 months
Patient global assessment of improvement
Time frame: 3 months
Clinical satisfaction of each patient
Time frame: 3 months
Subjective assessment of any encountered adverse effects
Time frame: 3 months
Patient satisfaction regarding characteristics of the used topical treatment
Time frame: 3 months
Dermatology Life Quality Index (DLQI)
Time frame: 3 months
Assessment of relapse
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 38170256Mogawer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
heba ahmed, Msc in dermatolo principal investigator
Kasralainy Hospital, Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing the optimized sodium valproate-loaded nanospanlastic dispersion and mometasone furoate lotion in people with Alopecia Areata, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Treatment success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.