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Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Calcipotriol
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with non-severe alopecia areata , a severity of alopecia tool (SALT) score up to 2 with less than 50% of scalp involvement. No restriction of age , race, nor occupation Exclusion Criteria: Pregnant and lactating women, immunocompromised patients. Patients having active scalp inflammation. Patients who received systemic treatment for Alopecia Areata in the last 3 months or applied any topical or intradermal treatments in the last 4 weeks .

Sites / Locations

  • Faculty of Dentistary - Aswan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

About 20 patients suffering from Alopecia areata , they will receive topical vit D3 analogue (calcipotriol) 0.005% twice daily for 3 months with follow up

About 20 patients suffering from Alopecia areata , they will be injected by PRP intra lesional for 3 consecutive sessions 4weeks apart.

About 20 patients suffering from Alopecia areata they will receive combined therapy ( PRP and topical vit D3 analogue).

About 20 of Healthy control group .

Outcomes

Primary Outcome Measures

Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment
Evaluating the patients suffering from Alopecia Areata clinically, with Severity of Alopecia Tool (SALT) score. As score of 0 means no hair loss, while a SALT score of 100 is complete hair loss. and this evaluation will be done by trichoscopy

Secondary Outcome Measures

serum adiponectin level.
Compare the effect of topical calcipotriol, PRP, and combination of both on serum adiponectin level.by doing the ELISA test for Alopecia Areata patients before treatment and 3 months after treatment
serum Adiponectin level in Alopecia Areata
Compare serum adiponectin level in Alopecia Areata patients with its serum level in healthy control group.by doing the ELISA test for Alopecia Areata patients before treatment and for healthy control group.

Full Information

First Posted
June 23, 2023
Last Updated
October 17, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05954104
Brief Title
Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma
Official Title
Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma Versus Combined of Both on Serum Adiponectin Level in Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alopecia areata (AA) is a common, immune-mediated non scarring alopecia and can be associated with severe psychological consequences . Alopecia Areata affects 2% of the global population. Alopecia Areata prevalence is lower in adults than children, is increasing over time, and significantly differs by region. Its etiology is unknown but it was hypothesized to be an autoimmune disease mediated by T-lymphocytes. It has been suggested that inflammatory T cells induce growth arrest in hair bulbs in the anagen phase of the hair cycle . Cytotoxic T cells secrete tumor necrosis factor, granzymes, and Fas ligand which trigger apoptosis in affected hair follicle and disrupt hair growth
Detailed Description
Clinically, Alopecia Areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp . Dermoscopy is a highly valuable tool in diagnosis and follow-up of Alopecia Areata. The most common trichoscopic features of Alopecia Areata are yellow dots, micro exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs . The diagnosis of alopecia areata is commonly established based on clinical appearance, In cases of ambiguity, trichoscopy may be useful to avoid invasive procedures such as biopsy. Treatment of alopecia areata is dependent on age of patient as well as the extent and duration of scalp involvement. Treatments include steroids, topical immunotherapy, topical minoxidil, anthralin, and immunosuppressants. Each case must be dealt with on a customized individual basis. Platelets rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma. Injection of PRP improves cutaneous ischemic conditions, increases vascular structures around hair follicles and induces the proliferation of dermal papilla cells by up regulating fibroblast growth factor 7 (FGF-7) .Anagen-associated angiogenesis has been suggested as one of the important factors in active hair growth, due to the secretion of vascular endothelial growth factor by the keratinocytes of the outer root sheath and fibroblasts of the dermal papilla . Topical calcipotriol is a vitamin D analogue that regulates keratinocytes proliferation and differentiation. It can induce hair regrowth in Alopecia Areata lesions by regulation of the differentiation of B cells, T cells, dendritic cells, and Toll-like receptor expression. There are few reports evaluating the effect of calcipotriol in Alopecia Areata . Patients with Alopecia Areata are characterized by an abnormal serum level of adipokines, particularly adiponectin and resistin. Adiponectin may be considered as a marker of severity of hair loss in alopecia areata. Impaired secretion of specific adipokines may play an important and complex role in the pathogenesis of Alopecia Areata and its continuity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
About 20 patients suffering from Alopecia areata , they will receive topical vit D3 analogue (calcipotriol) 0.005% twice daily for 3 months with follow up
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
About 20 patients suffering from Alopecia areata , they will be injected by PRP intra lesional for 3 consecutive sessions 4weeks apart.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
About 20 patients suffering from Alopecia areata they will receive combined therapy ( PRP and topical vit D3 analogue).
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
About 20 of Healthy control group .
Intervention Type
Drug
Intervention Name(s)
Calcipotriol
Other Intervention Name(s)
Platelet Rich Plasma
Intervention Description
To evaluate the efficacy of Calcipotriol on Alopecia Areata.
Primary Outcome Measure Information:
Title
Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment
Description
Evaluating the patients suffering from Alopecia Areata clinically, with Severity of Alopecia Tool (SALT) score. As score of 0 means no hair loss, while a SALT score of 100 is complete hair loss. and this evaluation will be done by trichoscopy
Time Frame
from baseline to 3 months
Secondary Outcome Measure Information:
Title
serum adiponectin level.
Description
Compare the effect of topical calcipotriol, PRP, and combination of both on serum adiponectin level.by doing the ELISA test for Alopecia Areata patients before treatment and 3 months after treatment
Time Frame
from baseline to 3 months
Title
serum Adiponectin level in Alopecia Areata
Description
Compare serum adiponectin level in Alopecia Areata patients with its serum level in healthy control group.by doing the ELISA test for Alopecia Areata patients before treatment and for healthy control group.
Time Frame
from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with non-severe alopecia areata , a severity of alopecia tool (SALT) score up to 2 with less than 50% of scalp involvement. No restriction of age , race, nor occupation Exclusion Criteria: Pregnant and lactating women, immunocompromised patients. Patients having active scalp inflammation. Patients who received systemic treatment for Alopecia Areata in the last 3 months or applied any topical or intradermal treatments in the last 4 weeks .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa Adam, Professor
Organizational Affiliation
Department of dermatology , Venerolgy and Andrology Faculty of Medicine Aswan university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistary - Aswan University
City
Aswan
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma

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