NCT07816575

Brief Summary

The aim of this double blind comparative clinical study is to evaluate the efficacy of AHAs combined with nanocarriers and their use as a non steroidal alternative drug for long term management of plaque psoriasis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

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

March 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in PASI Score.

    Reduction in PASI score from baseline to week 8.

    Baseline and 8 weeks

Secondary Outcomes (1)

  • Dermatology Life Quality Index (DLQI)

    Baseline and 8 weeks).

Other Outcomes (1)

  • Frequency of Adverse Events

    Throughout the study period (up to 8 weeks)

Study Arms (4)

Alpha Hydroxy Acids with Nanocarriers Group

EXPERIMENTAL

Patients received Alpha Hydroxy Acids formulated with nanocarriers.

Drug: Alpha Hydroxy Acids with nanocarriers

Alpha Hydroxy Acids Group.

EXPERIMENTAL

Patients received Alpha Hydroxy Acids only.

Drug: Alpha Hydroxy Acids only.

Calcipotriol plus betamethasone Group.

ACTIVE COMPARATOR

Patients received calcipotriol plus betamethasone.

Drug: Calcipotriol plus betamethasone

Placebo Group

PLACEBO COMPARATOR

Patients received placebo comparator.

Other: Placebo.

Interventions

Topical Alpha Hydroxy Acids formulated with nanocarriers applied to psoriatic plaques.

Alpha Hydroxy Acids with Nanocarriers Group

Topical Alpha Hydroxy Acids only applied to psoriatic plaques.

Alpha Hydroxy Acids Group.

Topical calcipotriol plus betamethasone ointment applied to psoriatic plaques.

Calcipotriol plus betamethasone Group.

Vehicle control / Placebo topical application applied to psoriatic plaques

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from18-65 years old.
  • Denovo psoriatic patients and patients with no psoriasis therapy in the previous two months.

You may not qualify if:

  • Severe irritation and highly inflamed skin.
  • Pregnant and lactating females.
  • Patients with acute renal insufficiency.
  • Face, flexural and groin lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Hussien and cairo dermatology Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotrieneBetamethasone

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 11, 2026

Study Start

March 15, 2024

Primary Completion

July 3, 2025

Study Completion

September 10, 2025

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations