A Control Trial of the Efficacy and Safety of 0.025% Tretinoin Cream and Cream Based in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans

2566URMS0002

The goal of this randomized intra-individual design with a split-side axillary approach is to comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation in the treatment of axillary hyperpigmentation associated with acanthosis nigricans. The main questions it aims to answer are: * The efficacy of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans. * The safety of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans. Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.

2024-02-01

2024-05-01

2024-05-01

Recruiting

Early phase I

20

Inclusion Criteria: * The participants aged over 18 years with BMI more than 25 kg/m2, axillary hyperpigmentation associated with acanthosis nigricans Exclusion Criteria: * Vulnerable skin diseases * Infectious skin diseases * Other recent diseases involving the axillary * Other serious medical disorders e.g. liver disease * Any patients having received other therapies for up to 4 weeks prior to enrollment * Photosensitive skin * Immunocompromised host * Pregnancy and lactation * Receiving oral retinoids * Axillary tattoo

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intra-individual design with a split-side axillary approach, participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'They were allocated the treatment via simple randomization by a third investigator who was not involved in data collection and analysis. Participants were given unlabeled jars of the topical agents. Assessments regarding clinical efficacy will be conducted by an assessor blind to treatment allocation.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-04-17