Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
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|ClinicalTrials.gov Identifier: NCT03996252|
Recruitment Status : Terminated (The study team was not able to start the study and they never completed the IRB submission, so the study was terminated.)
First Posted : June 24, 2019
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses||Drug: Calcipotriene 0.005% Foam Drug: Efudex 5% Topical Cream||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp|
|Actual Study Start Date :||July 1, 2019|
|Actual Primary Completion Date :||January 1, 2020|
|Actual Study Completion Date :||June 8, 2020|
Experimental: Combination treatment arm
Combination of calcipotriene 0.005% foam (Sorilux) and Fluorouracil Cream, 5% USP (generic) applied for four consecutive nights for the treatment of scalp actinic keratoses.
Drug: Calcipotriene 0.005% Foam
Application of calcipotriene foam in conjunction with generic efudex cream to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
Drug: Efudex 5% Topical Cream
Application of generic efudex cream in conjunction with calcipotriene foam to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
- Percentage of change in the number of scalp actinic keratoses from baseline [ Time Frame: 8 weeks ]Determine the efficacy of calcipotriene 0.005% foam and 5-fluorouracil 5% cream for the treatment of scalp actinic keratoses following 4 nights of combination treatment. The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp at 8 weeks after treatment.
- Complete and partial (>75%) clearance of actinic keratoses [ Time Frame: 8 weeks ]To determine complete and partial (>75%) clearance of actinic keratoses at 8 weeks after treatment.
- Composite score of erythema, itching and skin pain after topical of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses. [ Time Frame: 4 days ]To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996252
|United States, Louisiana|
|Tulane University Medical Center|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Emily Powell, MD||Tulane Department of Dermatology|