Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

NCT ID: NCT01347957

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

Brief Summary

Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle formation and growth in both rat and mouse models. The NO gel induced major physiological, developmental, and structural changes in the skin of mammals to increase the number of hair follicles, follicle stem cell development and regeneration as well as hair shaft elongation, and accelerated hair growth rate. Based on our animal model findings, the investigators hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair growth in humans. The objective of this trial is to evaluate the safety and efficacy of this NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment schedule.

Conditions

Alopecia Androgenica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nitric Oxide (NO) Gel

Group Type: EXPERIMENTAL

Nitric Oxide (NO) Gel

Intervention Type: OTHER

Nitric Oxide (NO) Gel is created by premixing of contents from 2 separate gel bottles. The first bottle, NO gel, is a solution of sodium nitrite (14.6mM) in distilled water with hydroxyethylcellulose (molecular weight 50,000-1,250,000) added for gel formation. The second bottle, Releasing-stimulator gel, is a solution of maleic acid (14.6mM) and ascorbic acid (14.6mM) in distilled water with hydroxyethylcellulose added for gel formation.

Placebo Gel

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: OTHER

The placebo gel is created by premixing of contents from 2 separate gel bottles. The first bottle is phosphate-buffered saline. The second bottle is the second gel bottle (Releasing-stimulator gel) as described in experimental arm.

Interventions

Nitric Oxide (NO) Gel

Nitric Oxide (NO) Gel is created by premixing of contents from 2 separate gel bottles. The first bottle, NO gel, is a solution of sodium nitrite (14.6mM) in distilled water with hydroxyethylcellulose (molecular weight 50,000-1,250,000) added for gel formation. The second bottle, Releasing-stimulator gel, is a solution of maleic acid (14.6mM) and ascorbic acid (14.6mM) in distilled water with hydroxyethylcellulose added for gel formation.

Intervention Type: OTHER

Placebo gel

The placebo gel is created by premixing of contents from 2 separate gel bottles. The first bottle is phosphate-buffered saline. The second bottle is the second gel bottle (Releasing-stimulator gel) as described in experimental arm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male subjects >= 20 and <= 65 years of age.

2. Subjects with hair loss caused by androgenetic alopecia.

3. Subjects who are healthy without any serious diseases that require hospitalization during the study period.

4. Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

Exclusion Criteria

1. Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months

2. Subjects with diagnosis of cancer and is still on active therapies.

3. Subjects with diagnosis of an active disease and is still under regular treatment for this disease

4. Subjects with hair loss caused by a known chronic disease.

5. Subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide.

6. Subjects with thyroid disease.

7. Subjects iron-deficiency anemia.

8. Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations

9. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.

10. Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization.

11. Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih JUNG HSU

Role: PRINCIPAL_INVESTIGATOR

Dermatological department, CMUH

Locations

Dermatological Department, CMUH

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

CHIH JUNG HSU

Role: CONTACT

0953661694

Other Identifiers

DMR98-IRB-231

Identifier Type: -

Identifier Source: org_study_id