Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05634460

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Molluscum Contagiosum	Drug: potassium hydroxide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A patients in group A treated with 5% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations	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.
Active Comparator: group B patients in group B treated with10% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations	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.

Arm

Intervention/Treatment

Active Comparator: Group A

patients in group A treated with 5% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations

Drug: potassium hydroxide

Active Comparator: group B

patients in group B treated with10% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations

Drug: potassium hydroxide

Outcome Measures

Primary Outcome Measures

. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria <100 lesions no therapy within the earlier one month

Exclusion Criteria:

known hypersensitivity and immunodeficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMH	Abbottabad	KPK	Pakistan	22010

Sponsors and Collaborators

Combined Military Hospital Abbottabad

Investigators

Principal Investigator: Bushra Muzaffar, FCPS, CMH abbottabad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huma Farid, Dr. Huma Farid, Combined Military Hospital Abbottabad

ClinicalTrials.gov Identifier:

NCT05634460

Other Study ID Numbers:

CMHAtd-ETH-04-Derm-22

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Huma Farid, Dr. Huma Farid, Combined Military Hospital Abbottabad

potassium hydroxide 5% and 10% lotion

Additional relevant MeSH terms:

Molluscum Contagiosum

Study Results

No Results Posted as of Dec 2, 2022