Clinical trial · Interventional
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
NCT02126670CI-TRIAL-00021016completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACT01 | Drug | — | UNRESOLVED |
| Comp01 | Drug | — | UNRESOLVED |
| Comp02 | Drug | — | UNRESOLVED |
| Comp03 | Drug | — | UNRESOLVED |
| Comp04 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- ACT01 plus Comp01
- description
- ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
- interventionNames
- Drug: ACT01
- Drug: Comp01
- type
- ACTIVE_COMPARATOR
- label
- ACT01 plus Comp02
- description
- ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
- interventionNames
- Drug: ACT01
- Drug: Comp02
- type
- ACTIVE_COMPARATOR
- label
- ACT01 plus Comp03
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter. 2. Age 30-85 years, inclusive. 3. Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse). Exclusion Criteria: 1. Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease. 2. Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism. 3. Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit. 4. Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.
References
Publications (0)
Data not yet available
No reference posted for this study.