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

NCT05954104 | Completed DMC

• 1 other identifier: Faten Othman
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to 3 months

Secondary Outcomes (2)

• serum adiponectin level.

  from baseline to 3 months

• serum Adiponectin level in Alopecia Areata

  from baseline to 3 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Drug: Calcipotriol

Group B

ACTIVE COMPARATOR

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

Drug: Calcipotriol

Group C

ACTIVE COMPARATOR

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

Drug: Calcipotriol

Group D

ACTIVE COMPARATOR

About 20 of Healthy control group .

Drug: Calcipotriol

Interventions

Calcipotriol DRUG

To evaluate the efficacy of Calcipotriol on Alopecia Areata.

Also known as: Platelet Rich Plasma

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 5 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Dentistary - Aswan University

Aswān, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

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

Study Officials

• Moustafa Adam, Professor

  Department of dermatology , Venerolgy and Andrology Faculty of Medicine Aswan university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 20, 2023
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 15, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)