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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05634460
Other study ID # CMHAtd-ETH-04-Derm-22
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 1, 2022
Est. completion date August 31, 2022

Study information

Verified date November 2022
Source Combined Military Hospital Abbottabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Molluscum is a virus-related skin infestation which is commonly seen among children. Molluscipox virus, the largest human virus, causes it. MC typically manifests as a single or multiple dome-shaped, shiny, pearly white papules with a central dimple. In immunocompetent individuals, spontaneous resolution usually occurs within 18 months; however, the lesion may persist for several years. Asymptomatic lesions are common. It is also linked to a high risk of transmission and an increasing prevalence in global populations1-2. Patients may receive therapy for social and cosmetic reasons, and also to avoid spreading disease to others. Numerous modalities are currently available, including Potassium hydroxide, curettage, cryotherapy, disinfected needle pricking, photodynamic therapy, laser, salicylic acid, glycolic acid etc3-4. Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC. Because it is inexpensive and widely accessible, it has the potential to be a useful method for treating for MC in resource-constrained countries5-6. The purpose of this study is to examine two varied concentrations of Potassium hydroxide (5%-KOH vs 10%-KOH) among MC patients in order to determine the most effective KOH concentration to manage Molluscum Contagiosum among children.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 14 Years
Eligibility Inclusion Criteria <100 lesions no therapy within the earlier one month Exclusion Criteria: known hypersensitivity and immunodeficiency

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
potassium hydroxide
Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC.

Locations

Country Name City State
Pakistan CMH Abbottabad KPK

Sponsors (1)

Lead Sponsor Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary . Efficacy was classified as follows: • complete remission (= 90% clearance of lesions) • partial remission (60-90% clearance of lesions) • insignificant improvement (<60% clearance of lesions) 06 months
See also
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Completed NCT01348386 - Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum Phase 2/Phase 3
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Completed NCT03077750 - A Study of VBP-245 in Pediatric Patients With Molluscum Contagiosum Phase 2
Terminated NCT02024581 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum Phase 2
Completed NCT03377803 - Cantharidin Application in Molluscum Patients Phase 3
Withdrawn NCT03336372 - Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients Early Phase 1