CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Topical endoxifen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04616430
NCT04616430Phase 2Completed
CompareCT.gov

Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort

Atossa Therapeutics, Inc.·interventional·Posted Nov 5, 2020·Updated Jul 12, 2021

In Brief

A Phase 2 clinical trial evaluating Topical endoxifen and Placebo for Mammographic Breast Density. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMammographic Breast Density
CountriesSweden
CollaboratorsKarolinska Institutet

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2020
Enrollment StartApr 9, 2018
Primary CompletionSep 10, 2018
Study CompletionSep 4, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.7 years ago

Interventions

Topical endoxifendrug

topical solution

Placebodrug

topical