Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
Stopped early · Early Phase 1
Conditions studied: Actinic Keratoses
In brief
The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.
Key facts
- Study ID
- NCT03996252
- Run by
- Tulane University
- People needed
- 15
- Starts
- 2019-07-01
- Expected to finish
- 2020-06-08
- Last updated by the study team
- 2020-12-07
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age of at least 40 years.
- Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on the scalp.
- Ability and willingness of the patient to participate in the study (Informed consent is obtained)
You may not qualify if…
- Treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma
- Treatment area contains hypertrophic/hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy
- Recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
- Premenopausal Women (to avoid any risk of pregnancy)
- History of hypercalcemia or clinical evidence of vitamin D toxicity (avoidance of calcipotriene toxicity).
Where it is running
- Tulane University Medical Center — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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