Abstract | BACKGROUND: METHODS: This 10-patient, prospective, single-arm, open-label, single-center, 12-week, investigator-initiated proof of concept study assessed the efficacy, safety, and patient acceptance of pimecrolimus cream 1% twice daily. In addition to pimecrolimus cream, patients used facial emollient containing SPF 15 sunscreen and mild soap-free cleanser. Efficacy assessments were Investigator Global Assessment ( IGA) of disease severity and evaluation of uneven skin color, scaling, eczema, follicular keratosis, and pruritus. All efficacy assessments were reported on a 4-point scale (0 = none to 3 = severe). RESULTS: Of the 10 patients enrolled (aged: 12-35 years), all had intensive sun-exposure, 90% had skin type IV-V, and 80% completed the 12-week treatment. At baseline, mean IGA was 1.20 (mild-moderate), uneven skin color was 2.3 (moderate-severe) and scaling was 1.2 (mild). IGA decreased to 0.25 by week 12, uneven skin color improved by week 3 with near complete resolution by week 12 (mean = 0.38) and scaling resolved at week 3. Pruritus, eczema, and follicular keratosis remained at low levels from baseline throughout the course of the study. Patients consistently reported satisfaction with the treatment ("satisfied" or "very satisfied"). No adverse events were reported. CONCLUSIONS:
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Authors | Wayne H Fujita, Calogera L McCormick, Anne Parneix-Spake |
Journal | International journal of dermatology
(Int J Dermatol)
Vol. 46
Issue 7
Pg. 700-5
(Jul 2007)
ISSN: 0011-9059 [Print] England |
PMID | 17614797
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- pimecrolimus
- Tacrolimus
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Topics |
- Administration, Topical
- Adolescent
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Child
- Drug Administration Schedule
- Eczema
(drug therapy)
- Female
- Humans
- Hypopigmentation
(drug therapy, pathology)
- Male
- Pityriasis
(drug therapy, pathology)
- Prospective Studies
- Pruritus
(drug therapy)
- Severity of Illness Index
- Skin
(pathology)
- Tacrolimus
(administration & dosage, adverse effects, analogs & derivatives)
- Treatment Outcome
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