Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
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|ClinicalTrials.gov Identifier: NCT03996252|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
|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)|
|Estimated 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|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996252
|Contact: Emily Powell, MDfirstname.lastname@example.org|
|Contact: Laura Williams, MDemail@example.com|
|Principal Investigator:||Emily Powell, MD||Tulane Department of Dermatology|